BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR NVS STEIN

    MDR report key: 11289737 · Received February 5, 2021

    Report

    Report Number
    3009081593-2021-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    November 30, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K011369, K122558. 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 ULTRASAFE X100L PNG CLEAR NVS STEIN SAFETY DEVICE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SPRING OF THIS PRODUCT HAD FALLEN OFF SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185570 ULTRASAFE X100L PNG CLEAR NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 8312560

    Patients

    Seq Age Sex Outcome Treatment
    1