BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

    MDR report key: 19852168 · Received July 29, 2024

    Report

    Report Number
    3023359743-2024-00328
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Report Date
    October 16, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    RECEIVED VOICEMAIL FROM CONSUMER STATING HIS PEN NEEDLES DO NOT WORK. STATED, HE IS THROWING AWAY 30% OF THE PRODUCT DUE TO NEEDLE CLOG. RETURNED CALL. CONSUMER REPORTED, NO INSULIN FLOW WHEN PRIMING HIS PEN NEEDLES. CONSUMER PRIMES 2 UNITS. STATED, HE'S HAD THIS ISSUE OCCUR IN A COUPLE OF BOXES BUT IS ONLY REPORTING ONE LOT NUMBER AND ONE BOX TODAY BECAUSE THE OTHER BOX WAS DISCARDED. LOT: 3241370, CATALOG: 320883, DATE OF EVENT: UNKNOWN, SAMPLES: NO CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399434 PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320883 3241370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male