BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 20217284 · Received September 13, 2024

    Report

    Report Number
    3022699058-2024-00007
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 20, 2024
    Report Date
    November 25, 2024
    Manufacturer
    EMBECTA MEDICAL II LLC - PARSIPPANY, NJ
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    CONSUMER REPORTED, DEVICE IS NOT CLIPPING ANYMORE. STATED, SHE WAS ONLY ABLE TO CLIP 20 TIMES STATED, SHE IS CLIPPING 25G NEEDLE LOT: 1179175 CATALOG: 328235 DATE OF EVENT: 2024-20-08 SAMPLES: YES SENDING SHARPS CONTAINER AS REPLACEMENT. CL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536218 NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC - PARSIPPANY, NJ 328235 1179175 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female