BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE E/T

    MDR report key: 8420424 · Received March 14, 2019

    Report

    Report Number
    3003152976-2019-00204
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 20, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903008668
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT HAS BEEN RECEIVED 6 PICTURES FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PICTURES RECEIVED, IT CAN BE OBSERVED A PARTICLE INSIDE THE SYRINGE. DHR OF LOT 1801288 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. SINCE PHYSICAL SAMPLE HAS NOT BEEN RECEIVED, THE ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED. IT IS POSSIBLE THAT IF SYRINGE WAS FILLED WITH DRUG FROM A VIAL USING A NEEDLE, THIS PARTICLE COMES FROM THE RUBBER VIAL DUE TO CORING DEFECT (PARTICLE OF RUBBER DETACHED DUE TO NEEDLE PENETRATION). BUT SINCE THE PARTICLE CANNOT BE INSPECTED IT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL OF A BD¿ SYRINGE E/T HAD BLACK SPOT INSIDE. CUSTOMER¿S VERBATIM: ¿60ML SYRINGE:THE BARREL HAS FOREIGN MATTER (BLACK SPOT).THE EVENT WAS FOUND IN DILUTING COSTLY DRUG (NT4400)¿.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BARREL OF A BD¿ SYRINGE E/T HAD BLACK SPOT INSIDE. CUSTOMER¿S VERBATIM: ¿60ML SYRINGE:THE BARREL HAS FOREIGN MATTER (BLACK SPOT).THE EVENT WAS FOUND IN DILUTING COSTLY DRUG (NT4400).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216296 BD SYRINGE E/T HYPODERMIC SYRINGE FMF BECTON DICKINSON, S.A. 1801288 30382903008668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other