BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG RASPBERRY NVS STEIN

    MDR report key: 11234208 · Received January 26, 2021

    Report

    Report Number
    3009081593-2021-00004
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 21, 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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K011369, PMA / 510(K)#: K122558. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY GUARD ON THE ULTRASAFE X100L PNG RASPBERRY NVS STEIN DID NOT ACTIVATE AFTER INJECTING THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE GUARD DID NOT ACTIVATE AFTER NURSE INJECTED IT TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129320 ULTRASAFE X100L PNG RASPBERRY NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 9344142

    Patients

    Seq Age Sex Outcome Treatment
    1