BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16706827 · Received April 10, 2023

    Report

    Report Number
    16706827
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 21, 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

    PAJUNK EPIDURAL CATHETER TRAYS WITH HUB THAT BECOMES DISCONNECTED. THE EPIDURAL CATHETER IS LEFT EXPOSED TO PATIENT BED, AND THE DISTAL TIP HAS TO BE CUT, AND A NEW EPIDURAL KIT HAS TO BE OPENED FOR A NEW HUB TO BE REPLACED TO BE RECONNECTED TO PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1794439 NA EPIDURAL ANESTHESIA KIT OGE PAJUNK MEDICAL SYSTEMS, LP TAL151

    Patients

    Seq Age Sex Outcome Treatment
    1 12410 DA Female