BD Prefilled Normal Saline 306507Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00382903065073), received between Nov 27, 2017 and Feb 5, 2020 — classified as 9 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryJun 12, 2018Nonstandard Device

  IT WAS REPORTED THAT A (B)(6) FEMALE WITH A DIAGNOSIS OF HODGKIN¿S LYMPHOMA AND A PICC LINE IN PLACE HAD A POSITIVE BLOOD CULTURE FOR SERRATIA MARCESCENS ON (B)(6) 2018. THE PATIENT WAS TREATED AND DISCHARGED. THE PFGE PATTERNS FOR THIS INCIDENT ARE INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 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

  Patient problems: Bacterial Infection

  MAUDE report 7594798 ↗
• InjuryJun 11, 2018Microbial Contamination of Device

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WITH A DIAGNOSIS OF RESPIRATORY FAILURE AND SEPSIS AND A PICC LINE IN PLACE HAD A POSITIVE BLOOD CULTURE FOR SERRATIA MARCESCENS ON (B)(6) /2018. THE PATIENT WAS TREATED AND DISCHARGED. THE PFGE PATTERNS FOR THIS INCIDENT ARE INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 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 B

  Patient problems: Bacterial Infection

  MAUDE report 7589897 ↗
• InjuryJun 11, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH A DIAGNOSIS OF NEUROBLASTOMA AND A TUNNELED CENTRAL LINE HAD A POSITIVE BLOOD CULTURE FOR SERRATIA MARCESCENS ON (B)(6) 2018. THE PATIENT WAS TREATED AND DISCHARGED. THE PFGE PATTERNS FOR THIS INCIDENT ARE INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 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.

  Patient problems: Bacterial Infection

  MAUDE report 7589876 ↗
• InjuryJun 6, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A (B)(6) YEAR OLD, MALE PATIENT WITH A DIAGNOSIS OF MEDULLOBLASTOMA AND A PORT HAD A POSITIVE BLOOD CULTURE FOR SERRATIA MARCESCENS ON (B)(6) 2018. THE PATIENT WAS TREATED AND DISCHARGED. THE PFGE PATTERNS FOR THIS INCIDENT ARE INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 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 (B)(4) ABOUT A POTENTIAL EPIDEMIOLOGICAL LINK BETWEEN CATHETER RELATED BLOOD STREAM INFECTIONS AND THE S. MARCESCENS BACTERIUM. SPECIFICALLY, THE FDA AND (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

  Patient problems: Bacterial Infection

  MAUDE report 7576079 ↗
• InjuryJun 5, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT CONTRACTED AN IV SITE INFECTION WHILE USING A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE. THE PATIENT BELIEVED THIS LOOKED LIKE THE START OF SEPTICEMIA, WENT TO AN URGENT CARE, AND RECEIVED 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 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: Unspecified Infection

  MAUDE report 7571844 ↗
• InjuryMay 18, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT A PATIENT WITH MULTIPLE ANOMALIES STATUS POST CARDIAC SURGERY HAD POSITIVE PERIPHERAL BLOOD CULTURES FOR SERRATIA MARCESCENS. THE PATIENT WAS HOSPITALIZED, RECEIVED AN POSITIVE ECHO, AND IS A PRESUMED SERRATIA ENDOCARDITIS. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE. THE FACILITY WHERE THIS EVENT OCCURRED REMOVED THIS PRODUCT. *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

  Patient problems: Unspecified Infection

  MAUDE report 7527567 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT AN INFANT IN AN NICU TESTED POSITIVE FOR S. MARCESCENS WHILE USING A 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 3 ML SYRINGE. IT IS UNKNOWN WHAT SPECIFIC MEDICAL INTERVENTIONS MAY HAVE BEEN PROVIDED. IT WAS ALSO CONFIRMED THAT THE INFANT IS RECOVERING NICELY.

  Patient problems: Bacterial Infection

  MAUDE report 7478708 ↗
• MalfunctionApr 10, 2018Sediment, Precipitate Or Deposit In Device Or Device Ingredient

  IT WAS REPORTED THAT THE NURSE FOUND THE BD¿ PRE-FILLED NORMAL SALINE SYRINGE PRODUCT WAS NOT COMPLETELY FILLED AND THERE WAS ORANGE/ BROWN SEDIMENT IN THE SYRINGE WHEN THE SEALED PACKAGE WAS OPENED. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7411179 ↗
• MalfunctionNov 27, 2017Device Alarm System; Failure to Infuse

  IT WAS REPORTED WITH THE USE OF THE 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE WHEN USING THE FRANKLIN FLUSH 3 ML SYRINGE FILLED TO 3 ML, THE NURSES FREQUENTLY EXPERIENCE A HIGH PRESSURE ALARM AND THEY SYRINGE PUMP STOPS INFUSING. SOME OF THE FLUSH SYRINGES HAVE IRREGULARITIES INSIDE THE HUB AS COMPARED TO AN EMPTY BD SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060082 ↗