BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 8846645 · Received July 31, 2019

    Report

    Report Number
    2243072-2019-01541
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 17, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903282357
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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, THE PROBLEM ¿NO CLIPPING¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) PASSED FUNCTIONAL TEST. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFECLIP IS NOT CLIPPING THE NEEDLE WITH A BD NEEDLE CLIPPING DEVICE SAFE CLIP. THIS OCCURRED ON 3 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CONSUMER'S SAFECLIP IS NOT CLIPPING ANY NEEDLE.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AS NYPRO, MX IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFE CLIP IS NOT CLIPPING THE NEEDLE WITH A BD NEEDLE CLIPPING DEVICE SAFE CLIP. THIS OCCURRED ON 3 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CONSUMER'S SAFE CLIP IS NOT CLIPPING ANY NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640817 BD NEEDLE CLIPPING DEVICE SAFE CLIP PISTON SYRINGE FMF BECTON DICKINSON 8288025 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other