BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 10849703 · Received November 17, 2020

    Report

    Report Number
    2243072-2020-01838
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Date of Event
    October 2, 2020
    Report Date
    March 4, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. 3 PHOTOS OF A SAFECLIP DEVICE FROM LOT 7177532 WERE PROVIDED. CUSTOMER STATES THAT THE NEEDLE CUTTER DOES NOT WORK SINCE WHEN TRYING TO CUT THE NEEDLE IT CANNOT BE DONE AND IT SEEMS AS IF THE EDGE HAS BEEN LOST/IS BLUNT. THE PHOTOS WERE REVIEWED, AND IT WAS OBSERVED THAT THE USER WAS UNABLE TO PROPERLY CLIP THE PATIENT END CANNULA OF A PEN NEEDLE. NO PHOTOS SHOWING THE CONDITION OF THE CUTTER BLADE WERE PROVIDED. THE CAUSE FOR THIS ISSUE COULD NOT BE DETERMINED BASED ON THE PHOTOS PROVIDED. ACCORDING WITH THE DHR REVIEW INFORMATION ABOVE, THE PROBLEM ¿NOT CLIPPING¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE CLIPPING DEVICE SAFE CLIP WAS NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CAREGIVER STATES THAT THE NEEDLE CUTTER DOES NOT WORK SINCE WHEN TRYING TO CUT THE NEEDLE IT CANNOT BE DONE AND IT SEEMS AS IF THE EDGE HAS BEEN LOST/IS BLUNT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE CLIPPING DEVICE SAFE CLIP WAS NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CAREGIVER STATES THAT THE NEEDLE CUTTER DOES NOT WORK SINCE WHEN TRYING TO CUT THE NEEDLE IT CANNOT BE DONE AND IT SEEMS AS IF THE EDGE HAS BEEN LOST/IS BLUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322888 NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 7177532 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1