BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-BALLOON 20F

    MDR report key: 2162045 · Received July 12, 2011

    Report

    Report Number
    3006260740-2011-00220
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 23, 2011
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915837
    Adverse Event
    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 BREAK IN THE RETENTION DOME WAS OBSERVED. A SECTION OF THE BROKEN DOME IS STILL ATTACHED TO THE FEEDING TUBE AND REVEALS A COMPLETE BOND ON GROSS AND MICROSCOPIC EXAMINATIONS. A CROSS SECTIONAL VIEW OF THE BREAK SITE REVEALS A DULL VENEER. MATING THE BROKEN DOME TOGETHER AT THEIR BREAK POINTS REVEALS A CLOSE MATCH. THE BREAK SITE REVEALS 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. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A LHR 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 186 DAYS. THE BROKEN DOME WAS REMOVED UNDER ENDOSCOPIC GUIDANCE. THE SIMILAR RETENTION DOME BREAK OCCURRED AT THIS HOSPITAL AT THE END OF LAST YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-BALLOON 20F KNT C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention