BD Prefilled Normal SalineRecalls & reported problems across all models

We found 3 models of BD Prefilled Normal Saline by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2017 and Feb 5, 2020 — classified as 3 deaths, 30 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (24 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BD Prefilled Normal Saline problems

BD Prefilled Normal Saline models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Prefilled Normal Saline 306500

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 deaths29 reports
• BD Prefilled Normal Saline 306507

  Catheter,intravascular,therapeutic,short-term less than 30 days
  14 reports
• BD Prefilled Normal Saline 306502

  Catheter,intravascular,therapeutic,short-term less than 30 days
  3 reports

Recent BD Prefilled Normal Saline adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2020Short Fill; Short Fill

  IT WAS REPORTED THAT WHILE USING 0.9% NORMAL SALINE 3ML FILL IN 3ML SYRINGE, NURSING STAFF BECAME CONCERNED THE FULL VOLUME WAS NOT BEING DELIVERED WHEN USED IN THE HOSPITAL'S BD ALARIS PUMP. WHEN NURSING STAFF TESTED THE SYRINGES, THEY FOUND ONLY 4ML WAS DELIVERED WHEN 6ML THAT WAS PROGRAMMED INTO THE BD ALARIS PUMP. NO INJURY OR DETERIORATION IN PATIENT CONDITION WAS REPORTED RELATED TO UNDERDOSING.

  Patient problems: Underdose

  MAUDE report 9673050 ↗
• MalfunctionJun 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE NORMAL SALINE 5ML FILL IN 10ML SYRINGE EXPERIENCED A WRONG TIP CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306502, BATCH NO.: 811511D. PER EMAIL: WE RECEIVED A VOICEMAIL FROM A PHARMACIST REQUESTING ASSISTANCE WITH PRODUCT NUMBER 306502 LOT 811511D. THE CUSTOMER STATED THAT THE CAPS ON THE PREFILLED NORMAL SALINE SYRINGES ARE BLUE INSTEAD OF WHITE AND THEY ARE BEING CONFUSED WITH HEPARIN INJECTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8677054 ↗
• 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 ↗
• MalfunctionDec 6, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FEW BD¿ PRE-FILLED NORMAL SALINE SYRINGES HAD A "MILKY SUBSTANCE" IN THEM.

  Patient problems: No Information

  MAUDE report 8137951 ↗
• 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 18, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT A HOME CARE PATIENT TESTED POSITIVE FOR A SERRATIA BLOOD STEAM INFECTION ON (B)(6) 2018 AND A SECOND TIME ON (B)(6) 2018. THE REPORTING FACILITY INDICATED THAT THE CDC STATED THAT THE SECOND INFECTION WAS A MATCH FOR THE SERRATIA STRAIN. THE PATIENT WAS TREATED FOR THE INFECTIONS BUT DETAILS REGARDING SPECIFIC MEDICAL INTERVENTION WAS NOT PROVIDED. A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 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. 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

  Patient problems: Bacterial Infection

  MAUDE report 7698512 ↗
• MalfunctionJul 17, 2018Component Missing

  IT WAS REPORTED THAT THE 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE WAS MISSING THE END OF THE PLUNGER FROM THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7694644 ↗
• MalfunctionJul 6, 2018Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE TIP OF A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7666844 ↗

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