BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 20194718 · Received September 11, 2024

    Report

    Report Number
    1920898-2024-00141
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 19, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    50382903010276
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED AND ANALYZED BY OUR QUALITY TEAM. THE PHOTO SHOWS WHAT APPEARS TO BE A HAIR IN THE THREADS OF THE SYRINGE. THE COMPLAINT IS VERIFIED AND THE MANUFACTURER HAS BEEN MADE AWARE OF THE ISSUE. WITHOUT FURTHER INFORMATION OR A PHYSICAL SAMPLE FOR INVESTIGATION, THE ROOT CAUSE OF THIS OCCURRENCE REMAINS UNKNOWN. THE PRODUCTION HISTORY WAS ANALYZED AND THERE WERE NO ISSUES FOUND DURING QUALITY INSPECTIONS THAT WOULD LEAD TO THIS ISSUE.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PHOTO RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD 5 ML BNS SYRINGE, MODEL 301027, 1 BATCH, REPORTED FOREIGN MATTER. EYELASH FOUND IN 5ML SYRINGE NOZZLE (AS PER PHOTO ATTACHED ¿CONTAMINANT IN SYRINGE NECK) PART CODE 301027, BD LOT NUMBER: EITHER 2238829 OR 2300951.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516497 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE UNKNOWN 50382903010276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown