BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 9581673 · Received January 13, 2020

    Report

    Report Number
    2243072-2019-02995
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 4, 2019
    Report Date
    December 26, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: N/A. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF A BD SAFE CLIP WITH THE SHELF CARTON FROM LOT # 5208371. CUSTOMER STATES THAT IT STOPPED CUTTING THE NEEDLES. THE PHOTOS WERE EXAMINED AND NO PHYSICAL DEFECTS WERE OBSERVED ON THE SAFE CLIP. IT IS DIFFICULT TO DETERMINE IF THE SAFE CLIP IS ABLE TO CUT THE NEEDLE SOLELY FROM PHOTOS. 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 (SAMPLE PLAN C=0, AQL=1). INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS IT IS DIFFICULT TO DETERMINE IF THE SAFE CLIP IS ABLE TO CUT THE NEEDLE SOLELY FROM THE PHOTOS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FAILURE TO CLIP OCCURRED DURING USE WITH A NEEDLE CLIPPING DEVICE SAFE CLIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, ¿THE PATIENT'S FAMILY, REPORTS THAT SINCE 04 / DEC / 2019, THE SHORT NEEDLES WERE FALLING FAILURES, THERE WAS TO MAKE VARIOUS ATTEMPTS TO CUT THE NEEDLES. AS OF 10/12/2019, IT STOPPED, EVEN IF MULTIPLE ATTEMPTS ARE MADE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47350 NEEDLE CLIPPING DEVICE SAFE CLIP SAFE-CLIP FMI BECTON DICKINSON 5208371 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other