BD Prefilled Normal Saline 306500Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00382903065004), received between May 17, 2018 and Mar 19, 2019 — classified as 3 deaths, 19 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (17 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NORMAL SALINE 10ML FILL IN 10ML SYRINGE HAD FOREIGN MATTER. THE FOLLOWING WAS REPORTED, " IT WAS REPORTED THAT A CLUMP OF DEBRIS WAS FLOATING INSIDE. PER PIR FORM: LOT 817411A WITH A CLUMP OF DEBRIS FLOATING INSIDE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8433841 ↗
• MalfunctionMar 18, 2019Material Puncture/Hole

  IT WAS REPORTED THAT TWO BD¿ NORMAL SALINE 10ML FILL IN 10ML SYRINGES HAD HOLES IN THE SYRINGE, AND THE EVENT WAS FOUND WHEN ATTEMPTING TO FLUSH AN OCCLUDED PIV. CUSTOMER¿S VERBATIM: ¿IT WAS REPORTED THAT TWO SYRINGES FROM THE SAME LOT NUMBER HAVE HOLES IN THE SYRINGES FOUND WHEN ATTEMPTING TO FLUSH AN OCCLUDED PIV.¿

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428358 ↗
• MalfunctionOct 3, 2018Fluid/Blood Leak

  IT WAS REPORTED WITH THE USE OF THE 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931173 ↗
• MalfunctionSep 19, 2018Crack; Leak/Splash

  IT WAS REPORTED THAT THE BD PRE-FILLED NORMAL SALINE FILLED FLUSH SYRINGE HAD A CRACKED BARREL, CAUSING SALINE TO LEAK. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7890269 ↗
• MalfunctionSep 13, 2018Problem with Sterilization; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE WAS AN IMPURITY PEAK WITHIN 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGES AND THE STERILITY WAS QUESTIONED. THE SYRINGES WERE USED TO DILUTE STERILE RADIOPHARMACEUTICAL PRODUCTS AND AN IMPURITY PEAK WAS OBSERVED ON THE HPLC ANALYSIS OF THE FINAL PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874764 ↗
• InjuryAug 20, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WENT TO HER DOCTOR TO RECEIVE AN ABDOMINAL WOULD CULTURE. THE WOULD CULTURE INDICATED THE PATIENT HAD AN INFECTION AND SHE WAS PRESCRIBED DOXYCYCLINE AND PENICILLIN. THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WAS ASSOCIATED WITH THIS INCIDENT. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE (B)(4) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(4)¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7799638 ↗
• InjuryAug 17, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED IN (B)(6) 2017 WITH A URINARY TRACT INFECTION, PNEUMONIA, A BLOOD INFECTION AND THAT THE, "LINING OF HIS CHEST WAS INFECTED." IT IS UNKNOWN IF THE PATIENT RECEIVED ANY MEDICAL INTERVENTIONS. A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WAS ASSOCIATED WITH THIS INCIDENT. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(4)¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, (B)(4).

  Patient problems: Pneumonia; Unspecified Infection; Urinary Tract Infection

  MAUDE report 7795360 ↗
• MalfunctionAug 16, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT BEFORE USE OF THE 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE, "ONE OF THE FLUSHES IN ONE OF THE BOXES WAS TINTED IN COLOR. IT WAS BROWN AND IT HAD PARTICLES COMING OFF OF THE STOPPER. IT HAD WHAT APPEARED TO BE A CLUMP OF RUST ON THE STOPPER." THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7790600 ↗
• DeathAug 10, 2018Nonstandard Device

  A PATIENT DEATH WAS REPORTED. THE WIFE OF THE PATIENT INDICATED THAT 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGES WERE USED FOR A YEAR BEFORE THE PATIENT PASSED AWAY. WHEN THE PATIENT'S WIFE RECEIVED THE RECALL NOTICE SHE REPORTED THE INCIDENT. SHE DID NOT INDICATE IF THE PATIENT WAS HOSPITALIZED OR IF HE DIED FROM AN INFECTION BUT THAT SHE WAS CONCERNED AFTER RECEIVING THE RECALL NOTICE. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE

  Patient problems: Death

  MAUDE report 7772406 ↗
• InjuryJul 3, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT CONTRACTED AN INFECTION DUE TO BACTERIA IN HIS BLOOD AND EXPERIENCED VOMITING AND A FEVER. THE PATIENT WAS HOSPITALIZED FOR FIVE DAYS AND RECEIVED AN MRI AND CT SCAN. THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WAS ASSOCIATED WITH THIS INCIDENT. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE (B)(4) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(4)¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, (B)(4).

  Patient problems: Bacterial Infection; Fever; Vomiting

  MAUDE report 7660369 ↗
• InjuryJun 28, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT CONTACTED AN INFECTION THROUGH HER HICKMAN LINE AFTER RECEIVING STEM CELLS FROM HER SISTER. THE PATIENT WAS ADMITTED TO THE HOSPITAL FROM (B)(6) 2018 AND AGAIN FROM (B)(6) 2018 AND RECEIVED ANTIBIOTICS. THE PATIENT WAS POSITIVE FOR KLEBSIELLA AND ENTEROCOCCUS. IT IS UNKNOWN IF THE PATIENT HERSELF USED A BD DEVICE, BUT THE PATIENT'S SISTER'S PICC LINE WAS FLUSHED WITH A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. INFORMATION REGARDING THE PATIENT SISTER IS CAPTURED UNDER A SEPARATE MDR REPORT # 2134319-2018-00076. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED B

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 7646318 ↗
• InjuryJun 27, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT USED A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE ON HER PICC LINE WHICH IS USED TO DONATE STEM CELLS TO HER SISTER AND BECAME ILL WITH A COUGH, HIGH FEVER, AND LOSS OF APPETITE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT WENT TO AN URGENT CARE WHERE SHE WAS EVALUATED, DIAGNOSED WITH PNEUMONIA, AND GIVEN ANTIBIOTICS. INFORMATION REGARDING THE PATIENT SISTER IS CAPTURED UNDER A SEPARATE MDR REPORT # 2134319-2018-00077. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE (B)(6) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE (B)(6) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD

  Patient problems: Complaint, Ill-Defined; Fever; Pneumonia; Respiratory Distress

  MAUDE report 7642714 ↗
• InjuryJun 26, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT CONTRACTED AN INFECTION WITH FEVER AND CHILLS AND WAS ADMITTED TO A HOSPITAL OVERNIGHT. A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WAS ASSOCIATED WITH THIS INCIDENT. THE PATIENT ALSO REPORTED THAT HE DISCONTINUED USING THE DEVICE PRIOR TO HIS INFECTION. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOI

  Patient problems: Alteration In Body Temperature; Bacterial Infection; Chills

  MAUDE report 7639869 ↗
• DeathJun 26, 2018Nonstandard Device; Microbial Contamination of Device

  A PATIENT'S WIFE REPORTED THAT HER HUSBAND HAD PASSED AWAY ON (B)(6) 2017 DUE TO AN INFECTION IN HIS "BILIARY TUBE". THE PATIENT HAD A HISTORY OF PANCREATIC CANCER AND ALZHEIMER'S DISEASE AND WAS USING 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGES, IN 10 ML SYRINGE TWICE A DAY FROM (B)(6) 2003 THROUGH (B)(6) 2017. THE PATIENT'S DEATH CERTIFICATE INDICATES THAT THE PATIENT'S CAUSE OF DEATH WAS "AMBULATORY CANCER". OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND (B)(6) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND (B)(6) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(6)'S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD F

  Patient problems: Cancer; Death; Unspecified Infection

  MAUDE report 7639735 ↗
• InjuryJun 12, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT TESTED POSITIVE FOR AN UNSPECIFIED INFECTION ON (B)(6) 2017. THE PATIENT INDICATED THAT LAB WORK WAS NORMAL BUT THE INFECTION WAS FOUND WHEN HER PORT-A-CATH WAS REPLACED. IN EARLY (B)(6) 2018, THE PATIENT HAD HER PORT-A-CATH REPLACED AGAIN. THE PATIENT ASSOCIATED 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGES, IN 10 ML SYRINGE WITH THIS INCIDENT AND RECEIVES 36 BOXES OF THIS DEVICE EVERY THREE MONTHS AND STATES THAT SHE USES THIS DEVICE WHEN SHE HAS WOUNDS BECAUSE SHE IS ALLERGIC TO OTHER PRODUCTS. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE (B)(4) IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. (B)(4)¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING

  Patient problems: Unspecified Infection

  MAUDE report 7594814 ↗
• MalfunctionJun 12, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DURING USE A BD¿ PRE-FILLED NORMAL SALINE FILLED FLUSH SYRINGE WAS FOUND WITH FOREIGN MATTER "A WHITE STRING OF FLOATING DEBRIS IN THE FLUSH." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7593545 ↗
• InjuryJun 5, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT BECAME SICK IN (B)(6) AND HAD KIDNEY SURGERY. THE PATIENT ASSOCIATED HIS INCIDENT WITH A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. THE PATIENT DECLINED TO PROVIDED FURTHER INFORMATION. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, FDA, AND CDC.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7571452 ↗
• InjuryJun 5, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT CONTRACTED AN UNKNOWN INFECTION AND HAD TO GO TO AN EMERGENCY DEPARTMENT. THE PATIENT IMPLICATED THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WITH HER INFECTION AND STATED THAT HER DOCTOR WILL TAKE CARE OF THE MATTER. NO ADDITIONAL DETAILS ABOUT THIS EVENT HAVE BEEN PROVIDED AS OF THE DATE OF THIS REPORT. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT

  Patient problems: Unspecified Infection

  MAUDE report 7571384 ↗
• InjuryJun 5, 2018Contamination; Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT RECEIVED A STEM CELL INJECTION WITH A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. THE PATIENT STATED THAT HE HAD TO HAVE EMERGENCY SURGERY RIGHT AFTER. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FOR THIS INCIDENT. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD,

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7571115 ↗
• InjuryJun 5, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO A HOSPITAL ON (B)(6) 2018 THROUGH (B)(6) 2018 BECAUSE SHE DEVELOPED TWO INFECTIONS. THE PATIENT INDICATED THAT THE INFECTIONS WERE ASSOCIATED WITH THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. INFORMATION ABOUT SPECIFIC TREATMENT PROVIDED IN THE HOSPITAL WAS NOT PROVIDED. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE

  Patient problems: Unspecified Infection

  MAUDE report 7571114 ↗
• InjuryJun 5, 2018Nonstandard Device

  IT WAS REPORTED THAT WHILE USING A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE, A PATIENT EXPERIENCED PRESSURE/PAIN ACROSS HIS STOMACH DURING INSERTION. THE PATIENT HAD AN APPOINTMENT WITH HIS PHYSICIAN THE FOLLOWING DAY AND WAS TOLD HE NEEDED TO HAVE A PROCEDURE ON HIS BILIARY OPENING. THE BILIARY PROCEDURE WAS DONE ON (B)(6) 2018. THE PATIENT ALSO VISITED HIS ONCOLOGIST AND FOUND THAT HIS WHITE BLOOD CELL COUNT WAS HIGH AND WAS PRESCRIBED ANTIBIOTICS. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIEN

  Patient problems: Abdominal Pain; Discomfort; Unspecified Infection

  MAUDE report 7571048 ↗
• InjuryMay 29, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT CONTRACTED AN INFECTION AND HAD FEVER, FATIGUE, PALLOR, PAIN AND WEAKNESS WHILE USING A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE AT HOME ON HER PICC LINE. TWO INITIAL SETS OF CULTURES WERE TAKEN AND ON (B)(6) 2018 WERE POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS. THE SOURCE WAS REPORTED TO BE THE PATIENT'S PICC LINE BUT IT WAS NOT CHANGED. THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH IV VANCOMYCIN FOR SEVEN DAYS. THE PATIENT WAS DISCHARGED TO HOME AND RECEIVED IV DAPTOMYCIN FOR AN ADDITIONAL 10 DAYS. AS OF (B)(6) 2018, THE PATIENT INDICATED THAT SHE WAS STILL USING IV VANCOMYCIN AND HEPARIN LOCKS THROUGH HER PICC LINE AND ANTICIPATED USING THEM FOR AT LEAST ANOTHER WEEK. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS

  Patient problems: Fatigue; Fever; Staphylococcus Aureus; Unspecified Infection; Weakness

  MAUDE report 7550767 ↗
• InjuryMay 29, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT IN (B)(6), AN ABSCESS WAS FOUND ON THE TIP OF A PATIENT'S LIVER WHERE A FLUSH OCCURS. THE PATIENT HAD A HIGH TEMPERATURE, CHILLS, RECEIVED X-RAYS, AND WAS TAKEN TO CRITICAL CARE. A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WAS IMPLICATED IN THIS INCIDENT. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, FDA, AND CDC.

  Patient problems: Abscess; Alteration In Body Temperature; Bacterial Infection; Fever

  MAUDE report 7550749 ↗
• DeathMay 29, 2018Nonstandard Device; Microbial Contamination of Device

  A CONSUMER REPORTED THAT HER SISTER HAD AN INFECTION AND PASSED AWAY ON (B)(6) 2018. A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE WAS IMPLICATED WITH THIS INCIDENT. OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTING POSITIVE FOR THIS BACTERIUM. INVESTIGATIONS ARE ONGOING BY BD, FDA, AND CDC.

  Patient problems: Bacterial Infection; Death

  MAUDE report 7550747 ↗
• InjuryMay 29, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SWELLING, PAINFUL LEG MUSCLES, DIFFICULTY WALKING, SITTING, AND STANDING, AND HAD PAIN AND BURNING DURING URINATION. THE PATIENT WAS TREATED WITH LYRICA AND RECEIVED X-RAYS WHICH WERE UNREMARKABLE. THE PATIENT ASSOCIATED THESE SYMPTOMS WITH THE USE OF A 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE. *OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF PUBLIC HEALTH, BD VOLUNTARILY RECALLED CERTAIN LOTS OF BD POSIFLUSH¿ HEPARIN LOCK FLUSH AND BD¿ PRE-FILLED NORMAL SALINE FLUSH SYRINGES DUE TO A POTENTIAL FOR CONTAMINATION WITH SERRATIA MARCESCENS BACTERIUM. BD WAS NOTIFIED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND CDC IDENTIFIED A POTENTIAL CONNECTION BETWEEN REPORTS OF INFECTION IN A SMALL NUMBER OF PATIENTS CAUSED BY S. MARCESCENS ACROSS MULTIPLE STATES. CDC¿S INITIAL INVESTIGATION FOUND THAT AFFECTED PATIENTS HAD RECEIVED TREATMENT USING CERTAIN BD FLUSH PRODUCTS. TO DATE, THERE IS NO EVIDENCE OF BD FLUSH PRODUCT TESTIN

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Dysuria; Pain; Swelling

  MAUDE report 7550746 ↗