BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 11033217 · Received December 17, 2020

    Report

    Report Number
    2243072-2020-02093
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 23, 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

    INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. FOUR PHOTOS OF A BD SAFECLIP DEVICE FROM LOT# 7177532 WERE PROVIDED. THE CUSTOMER REQUESTS TO CHANGE THE NEEDLE CUTTER, AS SHE HAS DIFFICULTY CUTTING THE NEEDLE. THE PHOTOS WERE EXAMINED, AND IT WAS OBSERVED THAT A USED SAFECLIP DEVICE FROM LOT# 7177532 WAS PHOTOGRAPHED IN BOTH CLOSED AND OPEN POSITIONS (REGARDING THE CUTTER HOLE). FROM THE PHOTOS ALONE, IT COULD NOT BE DETERMINED IF THE DEVICE WAS UNABLE TO CLIP CANNULA PROPERLY. ACCORDING WITH THE DHR REVIEW 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 THAT WHILE USING BD NEEDLE CLIPPING DEVICE SAFE CLIP¿ THE DEVICE IS NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CUSTOMER INFORMS THAT ON 11/20/2020 SHE REQUESTS TO CHANGE THE NEEDLE CUTTER, AS SHE HAS DIFFICULTY CUTTING THE NEEDLE.

    Additional Manufacturer Narrative · 1

    (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 THAT WHILE USING BD NEEDLE CLIPPING DEVICE SAFE CLIP¿ THE DEVICE IS NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CUSTOMER INFORMS THAT ON 11/20/2020 SHE REQUESTS TO CHANGE THE NEEDLE CUTTER, AS SHE HAS DIFFICULTY CUTTING THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497237 BD NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 7177532 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1