BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1242925 · Received November 21, 2008

    Report

    Report Number
    3006260740-2008-00209
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 6, 2008
    Report Date
    November 14, 2008
    Manufacturer
    C.R BARD, INC. (BASD)
    Product Code
    KGC
    PMA / PMN Number
    K904779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF RETENTION DOME SEPARATION IS CONFIRMED. NO TEARS OR SPLITS IN THE DOME SHELF WERE REVEALED WHILE UNDER 20X MAGNIFICATION. THE ENTIRE CIRCUMFERENCE OF THE DOME SHELF SURFACE EXHIBITS ADHESIVE RESIDUE SUGGESTING THE RETENTION DOME HAD BEEN FIXED IN PLACE PRIOR TO THE COMPLAINT INCIDENT. A MAGNIFIED VIEW OF THE DOME SHELF REVEALED A CONSISTENT ADHESIVE BOND EXHIBITING NO VOIDS. HOWEVER, THE LONGEVITY OF THE DEVICE, DISCOLORATION AND EVIDENCE OF A COMPLETE BOND SUGGEST ANOTHER (OTHER) FACTOR(S) WAS (WERE) INVOLVED. 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 INDWELLING PERIOD WAS UNKNOWN. THE USER FELT THE DOME PORTION WAS BROKEN WHEN THE OBTURATOR WAS INSERTED UPON TRACTION REMOVAL. THE DEVICE WAS REMOVED ENDOSCOPICALLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention