BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1213959 · Received October 28, 2008

    Report

    Report Number
    3006260740-2008-00181
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 2, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915841
    Adverse Event
    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. UPON RECEIPT, A SEMI-CIRCULAR BREAK IN THE RETENTION DOME WAS OBSERVED. 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 THE DEVICE. THE LACK OF ASSOCIATED DAMAGE SUGGESTS THE TEAR IN THE DOME WAS CAUSED BY STRETCHING THE DOME MATERIAL BEYOND ITS ELASTIC LIMITS DURING REMOVAL. HOWEVER, THE EXACT MECHANISM OF DAMAGE IS UNDETERMINED AT THIS TIME. MATING THE BROKEN RETENTION DOME TO THE FEEDING TUBE SHOWED A CLOSE MATCH. THE COMPLAINANT INDICATES THE COMPLAINT SAMPLE HAD BEEN IN PLACE FOR APPROX 139 DAYS PRIOR TO THE COMPLAINT INCIDENT. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. A CHR OF LOT # HURF0476 SHOWED NO OTHER PROD COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELLING PERIOD WAS 139 DAYS. THE DOME PORTION WAS REMOVED ENDOSCOPICALLY. THE PROPER FOLDING OF THE RETENTION DOME WAS CONFIRMED ENDOSCOPICALLY DURING REMOVAL, BUT THE DEVICE GOT BROKEN WHEN THE USER WAS PULLING IT OUT FROM THE STOMA SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C. R. BARD INC. (BASD) HURF0476

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention