BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-BLLN. REPL. TUBE-20

    MDR report key: 527305 · Received February 23, 2004

    Report

    Report Number
    1223688-2004-00007
    Event Type
    Malfunction
    Date Received
    February 23, 2004
    Date of Event
    January 27, 2004
    Report Date
    February 4, 2004
    Manufacturer
    BARD ENDOSCOPIC TECHNOLOGIES, CR BARD
    Product Code
    KNT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOME BROKE OFF DURING PERCUTANEOUS TRACTION REMOVAL OF THE DEVICE 70 DAYS AFTER PLACEMENT. THE DOME PORTION WAS EXPELLED IN 2004 AFTER AN ENEMA WAS GIVEN TO THE PT. NUTRITION USED IS CZ-HA1 1000 ML/DAY AND THE MEDICATION USED WAS ALEVIATIN (PHENYTOIN-SODIUM) 300MG/DAY, PHENOBAL (PHENOBARBITAL 1.5G/DAY, GASMET (FAMOTIDINE 40 MG/DAY, AND THYRADIN-S (LEVOTHYROXINESODIUM) 5 TABLET/DAY. A TRI-FUNNEL G TUBE (000720) WAS USED AS REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-BLLN. REPL. TUBE-20 FEEDING TUBE KNT BARD ENDOSCOPIC TECHNOLOGIES, CR BARD 61 000631 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R