BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETER

    MDR report key: 192661 · Received October 16, 1998

    Report

    Report Number
    1018381-1998-00033
    Event Type
    Injury
    Date Received
    October 16, 1998
    Date of Event
    August 1, 1996
    Report Date
    September 21, 1998
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    BSO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED. EPIDURAL CATHETER BREAKAGE REPORTED. INFO WAS RECEIVED DUE TO LEGAL PROCEEDINGS REGARDING PT PROGRESS DURING AND AFTER CHILDBIRTH. THE PT WAS ADMITTED FOR LABOR AND AN EPIDURAL CATHETER FOR CONTINUOUS ANALGESIA INFUSION WAS INSERTED AFTER PT CONSENT FOR THE SAME. DURING LABOR SOME FETAL BRADYCARDIA WAS OBSERVED, HOWEVER, THE PT EVENTUALLY DELIVERED VAGINALLY, AND NO SEQUELAE WAS REPORTED REGARDING THE BABY. AFTER THE DELIVERY, THE NURSE STATE "CLE (CONTINUOUS LUMBAR EPIDURAL) CATHETER REMOVED WITH SNAP OF CATHETER AND LACK OF MARKED END WITH REMOVAL." ANESTHESIOLOGIST'S NOTE STATES: "APPARENTLY WHEN RN PULLED OUT CATHETER AT DELIVERY, THE BLACK DOT AT END OF CATHETER NOT IDENTIFIED. BACK-- NO CATHETER FRAGMENT PALPATED. RETAINED CATHETER. DISCUSSED WITH PT, THAT LITERATURE DICTATES NO TREATMENT AND NO RISK. PT VERY ACCEPTING OF SITUATION AND SEEMS COMFORTABLE AND UNCONCERNED." THE PT WAS DISCHARGED HOME ON 8/24/1996. ON 10/21/1996, THE PT WAS ADMITTED TO THE EMERGENCY ROOM WITH COMPLAINT OF NUMBNESS AND WEAKNESS IN THE LEFT LEG, WHICH SPEREAD TO THE RIGHT LEG WITH OCCASIONAL NUMBNESS IN UPPER EXTREMITIES. THE PT COMPLAINED OF SHOOTING PAIN TO THE LEFT LEG, WHICH HAD BECOME MORE SEVERE AND CONSTANT IN THE WEEK PRIOR TO ADMISSION TO THE ER. THE PT WAS EVALUATED AND DISCHARGED HOME FROM THE ER. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETER EPIDURAL CATHETER BSO ABBOTT LABORATORIES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other