BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 19991180 · Received August 15, 2024

    Report

    Report Number
    3022699058-2024-00006
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Report Date
    October 28, 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
    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 LEFT VOICEMAIL REPORTING THAT THE BD SAFE CLIP NEEDLE CLIPPER IS NOT CLIPPING. I RETURNED CONSUMER'S CALL AND HE STATED THE SAME. HE SAID THAT HE HAD PURCHASED THE SAFE CLIP ABOUT 2 WEEKS AGO AND IT IS NO LONGER CLIPPING THE NEEDLES. I ADVISED CONSUMER THAT THE SAFE CLIPS HAVE BEEN DISCONTINUED AND ARE NO LONGER AVAILABLE. CONSUMER REFUSED TO PROVIDE HIS MAILING ADDRESS, SAID THERE IS NO NEED FOR MAIL KIT IF THE PRODUCT CANNOT BE REPLACED. LOT #: 5211373; CATALOG #: 328235; DATE OF EVENT: UNKNOWN; SAMPLES: UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1683017 NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL II LLC - PARSIPPANY, NJ 328235 5211373 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male