BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE CLIPPING DEVICE SAFE CLIP

    MDR report key: 8753861 · Received July 2, 2019

    Report

    Report Number
    2243072-2019-01312
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 10, 2019
    Report Date
    August 13, 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
    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. AS PER QE, A DHR REVIEW OF THE RISK MANAGEMENT FILE FOR THIS ISSUE SHOWS THAT THE RISK FOR THIS ISSUE IS LOW. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFECLIP IS NOT CLIPPING, THIS IS OCCURRING DURING USE WITH A BD NEEDLE CLIPPING DEVICE SAFE CLIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SAFE CLIP IS NOT CLIPPING.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: 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 SAFECLIP IS NOT CLIPPING, THIS IS OCCURRING DURING USE WITH A BD NEEDLE CLIPPING DEVICE SAFE CLIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SAFE CLIP IS NOT CLIPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548675 BD NEEDLE CLIPPING DEVICE SAFE CLIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 8114008 00382903282357

    Patients

    Seq Age Sex Outcome Treatment
    1 Other