BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGES LS W/RED PLUNGER

    MDR report key: 8174603 · Received December 18, 2018

    Report

    Report Number
    8041187-2018-00490
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Date of Event
    December 10, 2018
    Report Date
    January 10, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    00382903022366
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD¿ SYRINGES LS W/RED PLUNGERS WERE COVERED IN MOLD. IT WAS REPORTED THAT THIS AFFECTED 400 DEVICES. INVESTIGATION SUMMARY: NO PHOTOS AND NO SAMPLES WERE RETURNED FOR INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED AND ROOT CAUSE COULD NOT BE DETERMINED. DHR- REVIEWED SYRINGE DHR AND NO ABNORMALITY DURING QA INSPECTION. NO SIMILAR NON-CONFORMANCE WAS DETECTED DURING IN-PROCESS AND OUTGOING INSPECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGES LS W/RED PLUNGERS WERE COVERED IN MOLD. IT WAS REPORTED THAT THIS AFFECTED 400 DEVICES.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BD¿ SYRINGES LS W/RED PLUNGERS WERE COVERED IN MOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016771 BD¿ SYRINGES LS W/RED PLUNGER SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 8201162 00382903022366

    Patients

    Seq Age Sex Outcome Treatment
    1 Other