BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NG TUBE W/OUT PREVENT FILTER

    MDR report key: 3061596 · Received April 11, 2013

    Report

    Report Number
    1018233-2013-01292
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 15, 2013
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    KNT
    PMA / PMN Number
    PRE AM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES: "X-RAYS MAY BE DONE TO CONFIRM TUBE PLACEMENT." "MEASURE INSERTION LENGTH CAREFULLY - EXCESSIVE INSERTION LENGTH OF TUBE INTO THE STOMACH MAY LEAD TO COILING AND/OR FORMATION OF TUBE-KNOT." "CONTINUE TO ADVANCE THE TUBE UNTIL THE MARKED POSITION ON THE TUBE IS REACHED. DO NOT ADVANCE BEYOND THE MARKED LENGTH AS COILING AND/OR KNOTTING OF THE TUBE IN THE STOMACH MAY OCCUR." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A KNOT WAS FOUND IN THE NG TUBE UPON REMOVAL. NO PATIENT INJURY REPORTED. THERE WERE NO PROBLEMS WHEN THE NG TUBE WAS INITIALLY INSERTED NASALLY. THE NG TUBE FUNCTIONED PROPERLY AFTER THE INITIAL PLACEMENT FOR 4 DAYS. UPON REMOVAL SOME RESISTANCE WAS MET, AND WHEN THE NG TUBE WAS REMOVED IT WAS NOTED TO BE KNOTTED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION BUT IT WAS VERY PAINFUL TO THE PATIENT AND HE DEVELOPED A NOSE BLEED THAT DID SUBSIDE AND LEFT HIS NOSE SORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154478 NG TUBE W/OUT PREVENT FILTER KNT PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1