BEUDAMED
    FDA Adverse Event Death Summary report: N

    BALLARD TRACH CARE

    MDR report key: 834620 · Received April 5, 2007

    Report

    Report Number
    834620
    Event Type
    Death
    Date Received
    April 5, 2007
    Date of Event
    March 1, 2007
    Report Date
    April 4, 2007
    Manufacturer
    KIMBERLY-CLARK CORPORATION
    Product Code
    BSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INTUBATED PATIENT TRANSFERRED FROM OSH (OUTSIDE HOSPITAL) WITH WORSENING RESPIRATORY DISTRESS, AND METABOLIC DISEASE. PATIENT ARRIVED WITH 2.5 ENDOTRACHEAL TUBE, NASAL GASTRIC TUBE, AND PICC LINE. ACCEPTING HOSPITAL DID CHEST X-RAY APPROXIMATELY FOUR HOURS AFTER ARRIVAL, BUT DETERMINED CATHETER PIECE TO BE "OUTSIDE" PATIENT DUE TO SIZE. NEXT DAY, ACCEPTING HOSPITAL REINTUBATED WITH TUBE OVER TUBE EXCHANGER, THEN LATER ADVANCED ETT APPROXIMATELY 0.5CM. CHEST X-RAY APPROXIMATELY EIGHTEEN HOURS LATER REVEALED APPROXIMATELY 6CM PIECE OF BROKEN SUCTION CATHETER BELOW THE TUBE EXTENDING FROM THE TRACHEA DOWN INTO THE RIGHT LUNG BASE AREA. DUE TO PATIENT'S SIZE AND SERIOUS CONDITION, SURGERY DECLINED TO REMOVE. PATIENT BECOME EXTREMELY DISTRESSED SEVERAL HOURS LATER. RESPIRATORY DECLINED AND DECISION WAS MADE BY ATTENDING MD TO RETRIEVE CATHETER. AFTER MULTIPLE ATTEMPTS THE CATHETER TIP WAS REMOVED, BUT PATIENT CONTINUED TO DETERIORATE AND EXPIRED. PER OSH FILMS, PATIENT MAY HAVE INADVERTENTLY TRANSFERRED WITH BROKEN CATHETER PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLARD TRACH CARE CATHETER, SUCTION, TRACHEAL BSY KIMBERLY-CLARK CORPORATION 201 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 DAY Death