BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 20786532 · Received November 26, 2024

    Report

    Report Number
    3023359743-2024-00706
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 26, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    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-CONFORMANCE'S 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 NEW TO INJECTING INSULIN, FINDING THE PEN NEEDLES TO CLOG DURING INJECTION. DOES NOT COMPLETE A FLOW CHECK. (3 PEN NEEDLES ON (B)(6) 2024) ADVISED CONSUMER PROPER PLACEMENT OF NON-PATIENT END AND TO COMPLETE A FLOW CHECK. CONSUMER REPORTED ON 1 PEN NEEDLE FOUND THE PATIENT END TO BE BENT WHEN REMOVED INNER SHIELD. UNKNOWN EVENT DATE. DC. LOT#: 4002181, CATALOG#: 320550, DATE OF EVENT: 11/01/2024, SAMPLE STATUS: DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850089 PEN NDL 32G 4MM PRO 100 BOX 1200 US Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 4002181 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose