BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 19779034 · Received July 18, 2024

    Report

    Report Number
    3023359743-2024-00304
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Report Date
    October 10, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903205509
    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

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (COMPONENT CODE, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS BENT PE AND BROKEN/BENT NPE CANNULA AND 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.

    Additional Manufacturer Narrative · 0

    6 NEEDLES AFFECTED. MEDWATCH SECTION C FOR THE AFFECTED PRODUCT IS ATTACHED.

    Description of Event or Problem · 0

    CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION. 12 PEN NEEDLES AFFECTED. LOT: 3241356, 3234698. CATALOG: 320550. DATE OF EVENT: UNKNOWN. SAMPLES: YES , CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466057 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 3241356 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male