BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPER SAFE-CLIP EUROPE

    MDR report key: 10241805 · Received July 7, 2020

    Report

    Report Number
    2243072-2020-00986
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 7, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 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). H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 NEEDLES CLIPPER SAFE-CLIP EUROPE WERE NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " ADVISED THAT THE SAFE CLIP ON OCCASION DOES NOT CUT AND THEY HAVE TO TWIST AND BEND BEFORE THE NEEDLE IS CLIPPED. CUSTOMER DOES NOT HAVE AN EMAIL ADDRESS."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). OEM MANUFACTURE: 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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 NEEDLES CLIPPER SAFE-CLIP EUROPE WERE NOT CLIPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ADVISED THAT THE SAFE CLIP ON OCCASION DOES NOT CUT AND THEY HAVE TO TWIST AND BEND BEFORE THE NEEDLE IS CLIPPED. CUSTOMER DOES NOT HAVE AN EMAIL ADDRESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707041 NEEDLE CLIPPER SAFE-CLIP EUROPE NEEDLE CLIPPING DEVICE FMI BECTON DICKINSON 9065013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other