BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORTRAK ENTERAL FEEDING TUE

    MDR report key: 2860263 · Received November 8, 2012

    Report

    Report Number
    3009124963-2012-00029
    Event Type
    Other
    Date Received
    November 8, 2012
    Date of Event
    August 21, 2012
    Report Date
    November 6, 2012
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    PMA / PMN Number
    K821906
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURY WAS REPORTED. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FOUNDED TO HAVE A THINNED OUT SECTION THAT HAD THE APPEARANCE OF A DEFLATED BALLOON. THE REMNANT PART OF THE TUBE RETRIEVED ENDOSCOPICALLY FROM THE PATIENT WAS NOT RECEIVED. THE LOT NUMBER AS NOT REPORTED. BASED ON THE REPORT FROM THE CUSTOMER, IT IS LIKELY THAT THE VIGOROUS SYRINGE PRESSURE USED TO TRY AND UNCLOG THE TUBE CAUSED THE BURST. THE INSTRUCTIONS FOR USE CLEARLY STATE WARNING: VIGOROUS SYRINGE FORCE SHOULD NOT BE USED TO IRRIGATE, ADMINISTER LIQUIDS OR UNBLOCK THE TUBE.

    Description of Event or Problem · 1

    EVENT DESC: THE TUBE SPLIT AT APPROXIMATELY THE 60 CM MARK WHILE IN THE PATIENT. THE DISTAL PART OF THE TUBE REMAINED IN THE PATIENT AND HAD TO BE ENDOSCOPICALLY RETRIEVED. THE TUBE WAS DETERMINED TO BE KINKED APPROXIMATELY 7 DAYS AFTER PLACEMENT. THE KINK WAS RELIEVED BY "REWIRING". TWO DAYS LATER, THE TUBE WAS DEEMED "CLOGGED". PATENCY WAS RESTORED BY "VIGOROUSLY FLUSHING THE TUBE". THE NEXT DAY, WHEN CHECKING FOR PATENCY, AIR WAS HEARD COMING FROM THE PATIENT'S MOUTH. THE TUBE WAS REMOVED HOWEVER, ONLY THE PROXIMAL 60 CM PORTION WAS RETRIEVED. AN X-RAY WAS PERFORMED AND THE REMNANT PART OF THE TUBE WAS FOUND. ENDOSCOPY WAS PERFORMED AND THE REMNANT TUBE WAS REMOVED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTRAK ENTERAL FEEDING TUE FEEDING TUBE (NASOGASTRIC TUBE) KNT CORPAK MEDSYSTEMS 20-9551TRAK2A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other