BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC J

    MDR report key: 9659322 · Received February 3, 2020

    Report

    Report Number
    9659322
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    October 28, 2019
    Report Date
    October 25, 2019
    Manufacturer
    AVANOS MEDICAL, INC.
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD J TUBE PLACEMENT. FLUSH OF D5 30CC Q6 HOURS TO FOLLOW. PATIENT WITH ACUTE RESPIRATORY DISTRESS AND FAILURE DUE TO ASPIRATION PNEUMONIA AND TRANSFER TO THE TICU 2 DAYS LATER. ON CT WAS FOUND TO HAVE SBO AT SITE OF J TUBE INSERTION. WITH RISING LACTIC ACID AND WORSENING STATUS, PATIENT WENT TO OR 2 DAYS LATER. FOUND TO HAVE BALLOON DILATED GREATER THAN 100CC CAUSING BOWEL NECROSIS OF SURROUNDING AREA. UNABLE TO ASPIRATED FLUID THROUGH PORT DURING THE OR. OR FINDINGS: J-TUBE BALLOON WAS THOUGHT TO BE FULLY DEFLATED TWO DAYS PRIOR TO THE OR. HOWEVER INTRAOPERATIVELY THE BALLOON WAS FOUND TO BE HYPERINFLATED AND TENSE (SIZE OF A LARGE LEMON) OBSTRUCTING THE LUMEN AND STRETCHING BOWEL WALL, CAUSING CONTUSION ON ONE SIDE OF THE BOWEL ALONG THE LINE OF MAXIMUM TENSION. THE BALLOON PORT WAS NONFUNCTIONAL (UNABLE TO ASPIRATE THE FLUID OUT USING SYRINGE PER USUAL FASHION) AND THE SIDE PORT WAS CUT USING MAYO SCISSORS TO RELEASE THE FLUID FROM THE BALLOON (~ 100CC). OLD J-TUBE THEN REMOVED (20FR (0200-20) LOT: AA9028N05) AND A NEW ONE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122831 MIC J TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT AVANOS MEDICAL, INC. 0200-20 AA9028N05

    Patients

    Seq Age Sex Outcome Treatment
    1 24820 DA