BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFE-CLIP

    MDR report key: 10371036 · Received August 5, 2020

    Report

    Report Number
    2243072-2020-01199
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 6, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    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 ¿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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFE-CLIP IS NOT CLIPPING NEEDLES WITH A BD SAFE-CLIP¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A PET OWNER STATED THE BD SAFE-CLIP IS NOT WORKING PROPERLY. IT IS NOT OPENING UP PROPERLY OR CLIPPING THE NEEDLES.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN (B)(4). AS NYPRO, MX 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. 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 NEEDLES WITH A BD SAFE-CLIP¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A PET OWNER STATED THE BD SAFE-CLIP IS NOT WORKING PROPERLY. IT IS NOT OPENING UP PROPERLY OR CLIPPING THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831156 BD SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 7306554 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other