BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G 4MM HP 5 BAG 50 BOX SAMPLE CA

    MDR report key: 22205076 · Received June 13, 2025

    Report

    Report Number
    3023359743-2025-00412
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Report Date
    June 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

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: D3 MANUFACTURER EMAIL ADDRESS.

    Description of Event or Problem · 0

    CONSUMER REPORTED PEN NEEDLE CLOG WHEN TAKING INJECTIONS. STATED, HE PRIMES 4 UNITS WHEN HE STARTS A NEW PEN. LOT: 1082134. CATALOG: 320556. DATE OF EVENT: UNKNOWN. SAMPLES: YES, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815274 PN 32G 4MM HP 5 BAG 50 BOX SAMPLE CA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320556 1082134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown