BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1031921 · Received April 17, 2008

    Report

    Report Number
    2523003-2008-00041
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 25, 2008
    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 PARTIAL 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 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. THE COMPLAINANT INDICATES THE COMPLAINT SAMPLE HAD BEEN IN PLACE FOR APPROXIMATELY 161 DAYS PRIOR TO THE COMPLAINT INCIDENT. THE BROKEN RETENTION DOME THAT CONTAINS THE ANCILLARY OBTURATOR WAS NOT RETURNED FOR EVAL. 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 INFO HAS BEEN PROVIDED BY THE COMPLAINT.

    Description of Event or Problem · 1

    A BREAK IN A RETENTION DOME DURING FRACTION REMOVAL. THE INDWELLING PERIOD WAS 161 DAYS. THE DOME PORTION WAS REMOVED WITH BOWEL MOVEMENT.

    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