BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-CLIP

    MDR report key: 10022497 · Received May 4, 2020

    Report

    Report Number
    2243072-2020-00714
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 13, 2020
    Report Date
    May 5, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (SAMPLE PLAN C=0 AND AQL=1). H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SAFE-CLIPS EXPERIENCED THE SAFECLIP NOT CLIPPING/JAMMED WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328235, BATCH NO: 7334560. VERBATIM: VOICEMAIL: CONSUMER LEFT VOICEMAIL STATING THAT HER SAFE CLIP NEEDLE CLIPPER IS NOT WORKING, IT APPEARS THAT SOMETHING IS STUCK IN IT. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SAFE-CLIPS EXPERIENCED THE SAFECLIP NOT CLIPPING/JAMMED WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328235 BATCH NO: 7334560. VERBATIM: VOICEMAIL: CONSUMER LEFT VOICEMAIL STATING THAT HER SAFE CLIP NEEDLE CLIPPER IS NOT WORKING, IT APPEARS THAT SOMETHING IS STUCK IN IT. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483657 SAFE-CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 328235 7334560 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other