BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-CLIP

    MDR report key: 10684931 · Received October 15, 2020

    Report

    Report Number
    2243072-2020-01652
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 18, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF (B)(6) 2020 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. 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 (SAMPLE PLAN C=0 AND AQL=1). BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD SAFE-CLIP JAMMED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SAFE CLIP ONLY CLIPPED ABOUT 300 NEEDLES AND THEN STOPPED CLIPPING. VERBATIM: CONSUMER REPORTED HIS SAFE CLIP ONLY CLIPPING ABOUT 300 NEEDLES AND THEN IT STOPPED CLIPPING."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD SAFE-CLIP JAMMED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SAFE CLIP ONLY CLIPPED ABOUT 300 NEEDLES AND THEN STOPPED CLIPPING. VERBATIM: CONSUMER REPORTED HIS SAFE CLIP ONLY CLIPPING ABOUT 300 NEEDLES AND THEN IT STOPPED CLIPPING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152673 SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 6305503 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other