BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 16706779 · Received April 10, 2023

    Report

    Report Number
    16706779
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 14, 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
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT EXPERIENCING CONTINUED PAIN WITH CONTRACTIONS AFTER MEDICATION ADMINISTERED PER PUMP. REGISTERED NURSE CALLED ANESTHESIA TO COME EVALUATE AFTER PATIENT WAS EXPERIENCING PAIN. PROVIDER CAME TO BEDSIDE AND NOTICED THE EPIDURAL CATHETER HAD DETACHED FROM THE HUB THAT ATTACHES TO THE EPIDURAL TUBING AND WAS LEAKING ONTO THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519596 NA EPIDURAL ANESTHESIA KIT OGE PAJUNK MEDICAL SYSTEMS, LP TAL101 0001404

    Patients

    Seq Age Sex Outcome Treatment
    1 8030 DA Female