BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

    MDR report key: 21291403 · Received February 3, 2025

    Report

    Report Number
    3023359743-2025-00080
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Report Date
    March 19, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED, AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS A BENT CANNULA NPE. BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, HE STATED THAT THERE IS NO INSULIN FLOW. LOT #: 4072041 CATALOG #: 320883 DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189685 PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320883 4072041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male