BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP NEEDLE CLIPPING AND STORAGE DEVICE

    MDR report key: 11152830 · Received January 11, 2021

    Report

    Report Number
    2243072-2021-00078
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 15, 2020
    Report Date
    March 30, 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 (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. ACCORDING WITH THE DHR REVIEW INFORMATION THE PROBLEM ¿NOT CLIPPING¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFE-CLIP¿ NEEDLE CLIPPING AND STORAGE DEVICE THE DEVICE WAS JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PATIENT'S GUARDIAN COMMUNICATES WITH INFORMING THAT THE NEEDLE CUTTER NO LONGER WORKS BECAUSE A NEEDLE GOT STUCK.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD SAFE-CLIP¿ NEEDLE CLIPPING AND STORAGE DEVICE THE DEVICE WAS JAMMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THE PATIENT'S GUARDIAN COMMUNICATES WITH INFORMING THAT THE NEEDLE CUTTER NO LONGER WORKS BECAUSE A NEEDLE GOT STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42406 BD SAFE-CLIP NEEDLE CLIPPING AND STORAGE DEVICE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 4048319 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1