BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX FR

    MDR report key: 22161811 · Received June 6, 2025

    Report

    Report Number
    3023359743-2025-00403
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Report Date
    June 6, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: 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

    HELLO, WE HAVE RECEIVED A REPORT OF MATERIAL VIGILANCE REGARDING THE USE OF PEN NEEDLES FROM A PATIENT. SHE USED A BOX OF BD MICRO-FINE ULTRA PRO 4MM PEN NEEDLES. SEVERAL NEEDLES WERE BLOCKED IN THE SAME BATCH. THIS CONCERNED THE BATCH: 4240137, REFERENCE: (B)(4) AND EXPIRATION ON 31/08/2029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619895 PEN NDL 32G 4MM PRO 100 BOX FR Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320562 4240137

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown