BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTIP PLUS

    MDR report key: 2979717 · Received February 20, 2013

    Report

    Report Number
    2979717
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 20, 2013
    Manufacturer
    TELEFLEX, INC
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE NIGHT, A THIRD YEAR ANESTHESIOLOGY RESIDENT PLACED AN EPIDURAL IN A OBSTETRIC PATIENT. THE PATIENT PRESENTED WITH OBESITY AND SCOLIOSIS WHICH COMPLICATED THE PROCEDURE. LOSS OF RESISTANCE TO AIR WAS USED TO IDENTIFY THE EPIDURAL SPACE AND AN ARROW FLEXTIP CATHETER WAS PLACED. THE NEEDLE WAS REMOVED WITH THE CATHETER RETAINED IN POSITION. THE BLUE HUB WAS PLACED ON THE END OF THE CATHETER. AN ATTEMPT TO INJECT A 3 ML LIDOCAINE TEST DOSE WAS MADE. THE MEDICATION COULD NOT BE INJECTED. THE BLUE HUB WAS REMOVED AND WAS OBSERVED TO BE NON-PATENT. A SECOND EPIDURAL WAS OPENED WITH THE BLUE HUB REMOVED FROM THAT AND PLACED ON THE CATHETER. THE PATIENTS CARE WAS CONTINUED IN THE USUAL FASHION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EPIDURAL PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74648 FLEXTIP PLUS KIT, EPIDURAL CATHETERIZATION OGE TELEFLEX, INC * RM2097059

    Patients

    Seq Age Sex Outcome Treatment
    1 *