BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16706851 · Received April 10, 2023

    Report

    Report Number
    16706851
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 19, 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 EPIDURAL KITS HAVE HUB THAT BECOMES DISCONNECTED EASILY. WE HAVE HAD MULTIPLE INSTANCES WHERE THE DISTAL END OF THE EPIDURAL CATHETER BECAME DISCONNECTED FROM THE HUB. SUBSEQUENTLY THE DISTAL PORTION OF THE CATHETER HAD TO BE CUT OFF, AND THEN AN ENTIRE NEW KIT HAD TO BE OPENED TO REPLACE JUST THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795329 NA EPIDURAL ANESTHESIA KIT OGE PAJUNK MEDICAL SYSTEMS, LP TAL151

    Patients

    Seq Age Sex Outcome Treatment
    1 9855 DA Female