BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG RASPBERRY NVS STEIN

    MDR report key: 9687436 · Received February 10, 2020

    Report

    Report Number
    3009081593-2020-00014
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 20, 2020
    Report Date
    January 21, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ULTRASAFE X100L PNG RASPBERRY NVS STEIN SAFETY GUARD DID NOT ACTIVATE. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PHYSICIAN USED THE INJECTION, BUT THE PRODUCT DID NOT ACTIVE THE SAFETY GUARD (NEEDLE-SHIELD) AFTER INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153988 ULTRASAFE X100L PNG RASPBERRY NVS STEIN ULTRASAFE MEG BECTON DICKINSON HUNGARY KFT (BD) 8117536

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other