BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT G-TUBES

    MDR report key: 2102812 · Received April 12, 2011

    Report

    Report Number
    3006260740-2011-00140
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 21, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A BREAK IN THE RETENTION DOME IS CONFIRMED, USER RELATED. UPON RECEIPT A PARTIAL SEMI-CIRCULAR BREAK IN THE RETENTION DOME WAS OBSERVED. A SMALL SECTION OF THE BROKEN DOME IS STILL ATTACHED TO THE FEEDING TUBE AND REVEALS A COMPLETE BOND ON GROSS AND MICROSCOPIC EXAMINATIONS. A CROSS SECTIONAL VIEW OF THE BREAK SITE REVEALS A DULL VENEER. MATING THE BROKEN DOME TOGETHER AT THEIR BREAK POINTS REVEALS A CLOSE MATCH. THE BREAK SITE REVEALS TRAITS THAT ARE INDICATIVE OF EXCESSIVE FORCE THAT WAS APPLIED DURING THE REMOVAL OF THIS DEVICE. THE LACK OF ANY ASSOCIATED DAMAGE SUGGESTS THE TEAR IN THE DOME WAS CAUSED BY STRETCHING THE DOME MATERIAL BEYOND ITS ELASTIC LIMITS DURING REMOVAL. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A LHR IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFORMATION HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. IT WAS SUSPECTED THAT THE BROKEN DOME FELL INTO THE STOMACH; HOWEVER, THE BROKEN DOME WAS NOT FOUND IN THE STOMACH UNDER MICROSCOPY. THE BROKEN DOME WAS LATER EXCRETED BY THE BOWEL MOVEMENT. THE INCIDENT OCCURRED ABOUT 182 DAYS AFTER THE DEVICE PLACEMENT. THE PATIENT WAS FEMALE. THE TUBE WAS FREE-FLOATING WITHIN THE STOMA PRIOR TO THE REMOVAL. THE USER REPORTED THAT THEY HANDLE THE PRODUCT PROPERLY AND OBSERVED THE EXCHANGING PERIOD AS INSTRUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT G-TUBES KNT C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention