BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM HP 5 BAG 50 BOX SAMPLE US

    MDR report key: 19111738 · Received April 15, 2024

    Report

    Report Number
    9616656-2024-05249
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 22, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    UDI-DI
    30382903205517
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    2 PEN NEEDLES AFFECTED BY EVENT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED WHEN INJECTING WITH THE 2ND GEN PEN NEEDLES ONLY, THE NEEDLE REALLY HURTS GOING INTO THE SITE AND COMING OUT OF THE SITE. DOES A FLOW CHECK WITH EACH INJECTION. DC. CONSUMER REPORTED - 2 PEN NEEDLES HARD TO ATTACH ONTO HIS PEN. LOT#: 1173074, CATALOG#: 320551 - SAMPLE PACK, DATE OF EVENT: 03-22-2024, SAMPLE STATUS: AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656431 PN 32G 4MM HP 5 BAG 50 BOX SAMPLE US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320551 1173074 30382903205517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown