BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL/SYRINGE DIPPER FOR ATOMLAB

    MDR report key: 20683122 · Received November 14, 2024

    Report

    Report Number
    20683122
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 18, 2024
    Report Date
    October 21, 2024
    Manufacturer
    MIRION TECHNOLOGIES (CAPINTEC), INC
    Product Code
    IWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DOSE CALIBRATOR DIPPER FELL APART WHILE ASSAYING DOSE. THE DIPPER HAD ONLY BEEN IN USE FOR A FEW MONTHS, IT SHOULD HAVE LASTED MUCH LONGER. IN THE PAST 4 YEARS WE HAVE HAD 6 TO 8 DIPPERS FALL APART. WE DO NOT DROP THE DIPPERS OR HANDLE THEM ROUGHLY. A DIPPER SHOULD LAST FOR YEARS, NOT MONTHS.

    Description of Event or Problem · 0

    DOSE CALIBRATOR DIPPER FELL APART WHILE ASSAYING DOSE. THE DIPPER HAD ONLY BEEN IN USE FOR A FEW MONTHS, IT SHOULD HAVE LASTED MUCH LONGER. IN THE PAST 4 YEARS WE HAVE HAD 6 TO 8 DIPPERS FALL APART. WE DO NOT DROP THE DIPPERS OR HANDLE THEM ROUGHLY. A DIPPER SHOULD LAST FOR YEARS, NOT MONTHS.

    Description of Event or Problem · 0

    DOSE CALIBRATOR DIPPER FELL APART WHILE ASSAYING DOSE. THE DIPPER HAD ONLY BEEN IN USE FOR A FEW MONTHS, IT SHOULD HAVE LASTED MUCH LONGER. IN THE PAST 4 YEARS WE HAVE HAD 6 TO 8 DIPPERS FALL APART. WE DO NOT DROP THE DIPPERS OR HANDLE THEM ROUGHLY. A DIPPER SHOULD LAST FOR YEARS, NOT MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2217152 VIAL/SYRINGE DIPPER FOR ATOMLAB HOLDER, SYRINGE, LEAD IWR MIRION TECHNOLOGIES (CAPINTEC), INC 086-242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown