BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 CA

    MDR report key: 21716098 · Received March 27, 2025

    Report

    Report Number
    3023359743-2025-00244
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 6, 2025
    Report Date
    March 27, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH REPORT IS BOTH AN INITIAL AND FINAL REPORT AS THE INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 3RD 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 10 PERCENT OF BOX TO CLOG DURING THE FLOW CHECK. INFORMED CALLER OF THE NON PATIENT END AND PLACEMENT. DC LOT # 4051705 CATALOG# 320555 DATE OF EVENT 03.06.2025 = 2 PEN NEEDLES DATE OF EVENT UNKNOWN - UNKNOWN AMOUNT SAMPLE STATUS DISCARD ONES WITH ISSUES. CAN SEND UNUSED SAMPLES FROM THIS BOX. DC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438148 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 Unknown