BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS EPIDURAL

    MDR report key: 322324 · Received March 20, 2001

    Report

    Report Number
    9610175-2001-00007
    Event Type
    Malfunction
    Date Received
    March 20, 2001
    Date of Event
    February 1, 2001
    Report Date
    February 15, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CAZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL (ABBOTT SPAIN) THAT STATES. "THE KIT WAS USED IN A PT DURING LABOR. THE REPORTER SAID THAT AFTER PLACING THE EPIDURAL NEEDLE, RPTR PLACED THE CATHETER. AS RPTR JAD AN UNEXPLAINED PORBLEM, RPTR REMOVED AND REINTRODUCED THE CATHETER, THEN RPTR MOVED COMPLETELY THE CATHETER AND THE NEEDLE AND RPTR OBSERVED THAT THE CATHETER WAS CUT OFF AT 4CM OF THE DISTAL END. THEY SUSPECT THAT THE PIECE CUT IS IN THE PATIENT'S EPIDURAL SPACE. AN MRI HAS BEEN PLANNED." ADDITIONAL INFO WAS RECEIVED FROM THE AFFILIATE: ANOTHER EPIDURAL CATHETER WAS PLACED SUCCESSFULLY FOR PAIN RELIEF. THE MEASUREMENT OF 4CM WAS AN ESTIMATED CALCULATION, IT WAS ACTUALLY 1.5CM. THE REPORTER BELIEVES THE PIECE IS OUTSIDE THE EPIDURAL SPACE SINCE THE PHYSICIAN COULD NOT REACH IT. THE PIECE IS SUSEPCTED TO BE WITHIN THE MUSCLE OR THE YELLOW LIGAMENT. THIS CATHETER IS NOT RADIOPAQUE. NO ADVERSE PT EFFECT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12461 CONTINUOUS EPIDURAL SPINAL TRAY CAZ ABBOTT LABORATORIES NA 69-449-VM

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other