BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16706828 · Received April 10, 2023

    Report

    Report Number
    16706828
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 22, 2023
    Report Date
    March 28, 2023
    Manufacturer
    PAJUNK MEDICAL SYSTEMS, LP
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEW PAJUNK EPIDURAL CATHETER TRAY WITH ALREADY BROKEN LOSS-OF-RESISTANCE SYRINGE IN KIT. ISSUE WAS NOT DISCOVERED UNTIL PROCEDURE WAS ALREADY IN PROGRESS. ATTENDING WAS ABLE TO GRAB A NEW LOSS-OF-RESISTANCE SYRINGE FROM ANESTHESIA WORK ROOM, BUT THIS COULD HAVE CAUSED PATIENT HARM. I HAVE HAD 2 OF THESE KITS WITH BROKEN LOSS-OF-RESISTANCE SYRINGES. THE OTHER PATIENT I HAD WITH THESE KITS, I BROUGHT AN EXTRA LOSS-OF-RESISTANCE SYRINGE WITH ME JUST IN CASE IT WAS BROKEN, WHICH IT HAD TURNED OUT TO BE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794440 NA EPIDURAL ANESTHESIA KIT OGE PAJUNK MEDICAL SYSTEMS, LP TAL151

    Patients

    Seq Age Sex Outcome Treatment
    1 8760 DA Female