BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 CA

    MDR report key: 21092611 · Received January 7, 2025

    Report

    Report Number
    3023359743-2025-00032
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Report Date
    March 13, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B4, G6, H2, H11. CORRECTION MADE TO D9 (DEVICE AVAILABILITY), H6 (INVESTIGATION TYPE, INVESTIGATION CONCLUSION). 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 THE PEN NEEDLES TO CLOG DURING FLOW CHECK, ON A FEW FROM 3 DIFFERENT BOXES. INFORMED CALLER OF NON-PATIENT END PLACEMENT. CALLER FOUND NON-PATIENT END NEEDLE BENT DURING THIS CALL. DC. LOT#: 3318747 = 12 PEN NEEDLES 1 BOX, LOT#: 4051705 = 5 PEN NEEDLES 1 OUT OF 2 BOXES, LOT: 4051705 = 5 PEN NEEDLES 2ND OUT OF 2 BOXES. CATALOG#" 320555 ALL 3 BOXES, DATE OF EVENT UNKNOWN. SAMPLE STATUS AWAITING SAMPLE ALL 22 PEN NEEDLES WILL RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883435 PEN NDL 32G 4MM PRO 100 BOX 1200 CA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320555 4051705

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose