BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1366079 · Received March 20, 2009

    Report

    Report Number
    3006260740-2009-00117
    Event Type
    Malfunction
    Date Received
    March 20, 2009
    Date of Event
    February 10, 2009
    Report Date
    February 26, 2009
    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, A PARTIAL SEMI-CIRCULAR BREAKING 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 NOT RETURNED FOR EVALUATION. THE DULL AND ROUNDED VENEER IDENTIFIED AT THE TIME 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 182 DAYS PRIOR TO THE COMPLAINT INCIDENT. GROSS VISUAL AND MICROSCOPIC EXAMINATION 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 INDWELL TIME WAS 182 DAYS. HALF A YEAR AGO, A PONSKY NBR AND PEJ WERE PLACED IN THE PATIENT AT THE FACILITY, AND THE PATIENT HAD BEEN CARED FOR AT HOME SINCE THEN. THE PONSKY NBR AND PEJ WERE THEN REMOVED TRADITIONALLY, DUE TO A BLOCKAGE IN THE PEJ. THE PONSKY WAS RE-INSERTED SUBSEQUENTLY. BECAUSE HALF A YEAR HAD PASSED SINCE THE PLACEMENT OF THE PONSKY, THE DEVICE WAS REPLACED IN 2009. CONSIDERING THE ABOVE CIRCUMSTANCE, THE USER ATTEMPTED TRACTION REMOVAL CAREFULLY, BUT THE RETENTION DOME WAS TORN.

    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