BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 8499637 · Received April 10, 2019

    Report

    Report Number
    8499637
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Date of Event
    February 6, 2019
    Report Date
    February 26, 2019
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NURSING STAFF NOTED THAT THE EPIDURAL CATHETER CAME APART FROM THE CONNECTOR. THE CATHETER WAS GOING INTO PATIENT'S BACK WHILE PATIENT WAS LYING ON THE BED, BECOMING CONTAMINATED. DUE TO A KNOWN ISSUE AND RECALL, THIS HAS BEEN OCCURRING FREQUENTLY ACROSS ALL SITES OF THE HEALTH SYSTEM. THE MANUFACTURER RECOMMENDS TAPING THE CONNECTION SITE WHILE THEY WORK TOWARDS A SOLUTION, HOWEVER THE TAPE IS NOT FULLY EFFECTIVE. THE PATIENT IN THIS EVENT REQUIRED 5 ATTEMPTS BEFORE THIS CATHETER WAS SUCCESSFULLY PLACED AND BECAME CONTAMINATED. MANUFACTURER RESPONSE FOR CATHETER SET, EPIDURAL, PERIFIX FX (PER SITE REPORTER): THE ISSUES ARE KNOWN BY THE MANUFACTURER AND THE PRODUCT HAS BEEN RECALLED. AT THIS TIME, THE RECOMMENDATION IS TO TAPE THE CONNECTION SITE. B BRAUN IS WORKING ON A PERMANENT SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295035 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MEDICAL, INC. 333512 0061500330

    Patients

    Seq Age Sex Outcome Treatment
    1 9125 DA