BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1211041 · Received October 24, 2008

    Report

    Report Number
    3006260740-2008-00165
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 29, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS CONFIRMED, BUT THE EXACT CAUSE IS UNKNOWN. THE RETENTION DOME TORE FROM THE PONSKY NON-BALLOON REPLACEMENT TUBE. THE DOME WAS DISCOLORED. IT WAS REPORTED THAT THE DOME BROKE DURING REMOVAL. A PORTION OF THE DOME REMAINED BONDED TO THE TUBE. THE DULL VENEER ALONG THE SURFACE OF THE REMAINING DOME MATERIAL INDICATES THAT THE DOME TORE. THE LACK OF ANY ASSOCIATED DAMAGE SUGGESTS THE TEAR IN THE DOME WAS CAUSED BY STRETCHING THE DOME MATERIAL DURING REMOVAL. THE COMPLAINANT INDICATES THE DEVICE HAD BEEN IN PLACE FOR 284 DAYS. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. DISCOLORATION AND DEFORMATION WAS NOTED BETWEEN THE 2CM DEPTH MARK AND THE PROXIMAL END OF THE PONSKY TUBE. A CHR WAS NOT COMPLETED SINCE THE LOT INFORMATION WAS NOT PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE DEVICE WAS PLACED IN 2007 AND REMOVED IN 2008. DURING REMOVAL, THE RETENTION DOME BROKE. THE DOME 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) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention