BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 19872910 · Received July 31, 2024

    Report

    Report Number
    3023359743-2024-00343
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Report Date
    October 22, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    100 PEN NEEDLES AFFECTED. MEDWATCH SECTION C FOR THE AFFECTED PRODUCT IS ATTACHED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS 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 NO INSULIN FLOW WHEN PRIMING 1 UNIT. STATED, NON OF THE PEN NEEDLES IN THE BOX WORKED. LOT: 3241357; CATALOG: 320550; DATE OF EVENT: UNKNOWN; SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239892 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 3241357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male