BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-BALLOON 20F

    MDR report key: 2142054 · Received May 19, 2011

    Report

    Report Number
    3006260740-2011-00144
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 28, 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
    NURSE

    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 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 MFG PROCESS. AN LHR IS NOT POSSIBLE, AS NO MFG LOT NUMBER INFO HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELL TIME WAS 119 DAYS. THE TUBE WAS FREE-FLOATING WITHIN THE STOMA PRIOR TO THE REMOVAL. THE DOME PORTION WAS LEFT IN THE STOMA, BUT LATER EXCRETED BY THE BOWEL MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-BALLOON 20F KNT C. R. BARD INC., (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention