BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 10371518 · Received August 6, 2020

    Report

    Report Number
    2243072-2020-01204
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 30, 2020
    Report Date
    August 5, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN AS NYPRO, MX IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR NOT CLIPPING DUE TO UNKNOWN LOT NUMBER. A REVIEW OF RISK MANAGEMENT 730RMN-0004-02 REVISION 04 INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SAFECLIP, NOT CLIPPING) WAS CAPTURED AND ADDRESSED 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. UNABLE TO PERFORM DHR CHECK FOR NOT CLIPPING DUE TO UNKNOWN LOT NUMBER. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CLIPPER IS NOT CLIPPING NEEDLES DURING USE WITH A BD SAFE-CLIP¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE CLIPPER IS NOT CLIPPING THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836553 BD SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 UNKNOWN 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other