BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 20280004 · Received September 23, 2024

    Report

    Report Number
    3023359743-2024-00498
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Report Date
    December 2, 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
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION AND INVESTIGATION CONCLUSIONS) 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 FINDING ONLY THE ITEM 320550 PATIENT END NEEDLE TO BEND DURING INJECTION. DENIED REUSE. INJECTS IN BACK OF ARM. DOES NOT PINCH UP. THE DOSE BUTTON GOES ALL THE WAY DOWN. BUT FEELS THE INSULIN DOES NOT GO INTO SITE. AT TIMES OUTER SKIN IS WET. (LEAKED OUT) USED UP THE BOX DOES NOT HAVE SAMPLES TO RETURN. SENDING 2 BOXES DIRECTLY TO HER PHARMACY. DC LOT # 3192217 CATALOG# 320550 DATE OF EVENT UNKNOWN SAMPLE STATUS DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487816 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 3192217 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female