BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALYARD HEALTH MIC-KEY

    MDR report key: 6771430 · Received August 3, 2017

    Report

    Report Number
    MW5071402
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 3, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD EXISTING J TUBE INSERTED (B)(6) 2016 IN OUR DEPARTMENT. THE PATIENT WAS ON OUR TABLE FOR REPLACEMENT (B)(6) 2017 AND WE DISCOVERED THAT THE TUBE WAS BROKEN. A SCOUT FILM BEFORE WE START AND THE SCOUT APPEARED TO SHOW A DISCONNECT IN THE CATHETER SUGGESTIVE OF A CATHETER FRACTURE. SURE ENOUGH IT WAS FRACTURED AND THE LARGER DISTAL PORTION (ESSENTIALLY THE WHOLE TUBE EXCEPT FOR A SMALL PORTION WHICH GOES INTO THE STOMACH REMAINED) APPEARED TO HAVE MIGRATED INTO THE LARGE BOWEL. THE PROXIMAL END OF THE G-J TUBE WAS REMOVED OVER THE WIRE, BUT THE BROKEN SECTION DISTALLY STAYED IN THE BOWEL. GENERAL SURGERY WAS CONSULTED, BUT UNLIKELY TO HAVE SURGICAL REMOVAL BASED ON NO SHARP EDGES THAT COULD CAUSE PERFORATION. PROXIMAL SECTION WAS GIVEN, WAS SENT TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546437 HALYARD HEALTH MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT KNT HALYARD HEALTH AA6095N26

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention