BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1543564 · Received November 19, 2009

    Report

    Report Number
    3006260740-2009-00390
    Event Type
    Injury
    Date Received
    November 19, 2009
    Date of Event
    October 28, 2009
    Report Date
    November 6, 2009
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915837
    Adverse Event
    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 BROKEN SECTION OF THE RETENTION DOME WAS MATED TO THE FEEDING TUBE AND REVEALS A CLOSE MATCH. THE COMPLAINANT INDICATES THE COMPLAINT SAMPLE HAD BEEN IN PLACE FOR APPROXIMATELY 135 DAYS PRIOR TO THE COMPLAINT INCIDENT. 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 DOME 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 OF DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A CHR OF LOT #HUTA0172 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER (231453).

    Description of Event or Problem · 1

    THE RETENTION DOME WAS DETACHED DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 135 DAYS. THE DOME PORTION WAS REMOVED ENDOSCOPICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C.R. BARD, INC. (BASD) HUTA0172

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention