BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREVI STF

    MDR report key: 6102203 · Received November 15, 2016

    Report

    Report Number
    6102203
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 17, 2016
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PAIN MANAGEMENT PHYSICIAN WAS DOING A CAUDAL EPIDURAL STEROID INJECTION WITH AN EPIDURAL CATHETER. THE CATHETER CONNECTOR WAS DEFECTIVE AS THE PHYSICIAN COULD NOT PUSH MEDICATION THROUGH THE CONNECTOR. THE CONNECTOR ALSO KINKED UP THE CATHETER. THE CATHETER WAS OK TO USE BUT WE NEEDED TO OPEN A NEW PACKAGE OF CATHETER WITH CONNECTOR IN ORDER TO FINISH THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753634 BREVI STF CATHETER, CONDUCTION, ANESTHETIC BSO EPIMED INTERNATIONAL, INC. 11436505

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR