BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP NEEDLE CLIPPER

    MDR report key: 10251895 · Received July 9, 2020

    Report

    Report Number
    2243072-2020-01032
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 22, 2020
    Report Date
    June 24, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. (B)(4). INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR NOT CLIPPING ON LOT # 9065013. A REVIEW OF RISK MANAGEMENT (B)(4) INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (SAFECLIP, NOT CLIPPING) WAS CAPTURED AND ADDRESSED APPROPRIATELY. ACCORDING WITH THE DHR REVIEW INFORMATION ATTACHED, 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 AND AQL=1). 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: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. 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 DURING USE THE SAFE-CLIP IS NOT CUTTING AND CUSTOMER HAS TO "TWIST AND BEND" NEEDLE TO CLIP WITH A BD SAFE-CLIP¿ NEEDLE CLIPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) CUSTOMER ADVISED THAT THE SAFE CLIP ON OCCASION DOES NOT CUT AND THEY HAVE TO TWIST AND BEND BEFORE THE NEEDLE IS CLIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719826 BD SAFE-CLIP NEEDLE CLIPPER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 9065013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other