BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 9296461 · Received November 8, 2019

    Report

    Report Number
    2243072-2019-02501
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 23, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903282357
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 3 DECEMBER 2019 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. ACCORDING WITH THE DHR REVIEW INFORMATION ABOVE, THE PROBLEM ¿NO CLIPPING¿ HAS NO NHB ASSEMBLY PROCESS RELATION, ALL SAMPLES OF SAFE CLIP DISPOSABLE CUTTER (USA) RELATED TO NMR PASSED FUNCTIONAL TEST AQL C=0 AND AQL=0.65, AND THE MATERIAL NOT INVOLVED IN THE NMR PASSED FUNCTIONAL TEST AQL C=0 AND AQL=1. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE CLIPPING DEVICE SAFE CLIP WOULD NOT CLIP THE "22G 1 1/2" NEEDLE" DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STOPPED CLIPPING. USING THE 22G 1 1/2" NEEDLE. USING FOR 6 MONTHS."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: 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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 NEEDLE CLIPPING DEVICE SAFE CLIP WOULD NOT CLIP THE "22G 1 1/2" NEEDLE" DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STOPPED CLIPPING. USING THE 22G 1 1/2" NEEDLE. USING FOR 6 MONTHS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088852 NEEDLE CLIPPING DEVICE SAFE CLIP NEEDLE CLIPPING DEVICE FMI BECTON DICKINSON 4050320 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other