BD Prefilled Normal Saline 306502Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903065028), received between May 24, 2018 and Jun 6, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Nonstandard Device” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJun 12, 2018Nonstandard Device

  IT WAS REPORTED THAT A PATIENT CONTACTED AN INFECTION AFTER HAVING HIS APPENDIX REMOVED. THE PATIENT HAD TO HAVE A DRAINAGE TUBE PLACED. THE PATIENT INDICATED THAT 5 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGES, IN 10 ML SYRINGE WERE USED. 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 7594808 ↗
• InjuryMay 24, 2018Nonstandard Device; Microbial Contamination of Device

  IT WAS REPORTED THAT THE (B)(4) CONFIRMED A CASE OF SERRATIA MARCESCENS BLOODSTREAM INFECTION FROM (B)(6) WITH PFGE PATTERNS INDISTINGUISHABLE FROM THE ORIGINAL CO OUTBREAK PATTERN. THE PATIENT IS A (B)(6) YEAR OLD MALE DIAGNOSED WITH LYMPHOMA AND IS IMMUNOCOMPROMISED WITH AN IMPLANTED PORT THAT WAS ACCESSED IN AN OUTPATIENT INFUSION CLINIC. THE PATIENT PRESENTED TO A HOSPITAL WITH POSITIVE SERRATIA MARCESCENS CULTURE ON (B)(6) 2018, WAS TREATED, AND SUBSEQUENTLY DISCHARGED. THE SPECIFIC TREATMENT PROVIDED IS UNKNOWN. THE DEVICE IMPLICATED WITH THIS INCIDENT IS A 5 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 (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 NUMB

  Patient problems: Bacterial Infection

  MAUDE report 7541305 ↗