BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 18773032 · Received February 23, 2024

    Report

    Report Number
    2243072-2024-05003
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Report Date
    May 20, 2024
    Manufacturer
    HDQ PARSIPPANY
    Product Code
    FMI
    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

    THE DATA OF THE FOLLOW-UP NUMBER 1 MEDWATCH REPORT SUBMISSION WAS MAY 19.

    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

    EMAIL COMPLAINT WAS SENT FROM BD TO EMBECTA. SENT: THURSDAY, FEBRUARY 1, 2024 11:52 AM-EMBECTA'S AWARENESS DATE. SENT: WEDNESDAY, JANUARY 31, 2024 7:11 PM-BD AWARENESS DATE. ___________________________ I BOUGHT A BD SAFE-CLIP FROM MY VETERINARIAN ON (B)(6) 2023. IT WORKED FINE FOR THE FIRST (B)(4)150 NEEDLES. I DIDN¿T EVEN GO THROUGH (B)(4) NEEDLES YET AND I CANNOT GET ANY MORE NEEDLES TO GO INTO IT. IT SAYS IT STORES (B)(4) NEEDLES. WHEN I TRY TO PUT A NEEDLE IN IT, IT WON¿T GO INTO THE HOLE. IT ACTS LIKE IT IS FULL. SO I CANNOT CUT THE NEEDLES OFF TO GO INTO THE DEVICE. INSULIN SYRINGE BEING USED IS 8MM X 31G. BD SAFE-CLIP NEEDLE CLIPPING & STORAGE DEVICE. LOT # 2195001. REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229325 NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI HDQ PARSIPPANY 328235 2195001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown