BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 2043123 · Received February 24, 2011

    Report

    Report Number
    3006260740-2011-00054
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 10, 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. THE DULL AND ROUNDED VENEER IDENTIFIED AT THE DOME SITE ARE 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 CHR 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. THE INDWELL TIME WAS 123 DAYS. THE DOME PORTION WAS REMOVED WITH BOWEL MOVEMENT 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention