BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1895379 · Received November 4, 2010

    Report

    Report Number
    3006260740-2010-00325
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 19, 2010
    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 SMALL SECTION OF THE BROKEN DOME IS STILL ATTACHED TO THE FEEDING TUBE AND REVEALS A COMPLETE BOND. 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. GROSS VISUAL AND MICROSCOPIC EXAMINATIONS SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. A CHR OF LOT #HUTA1528 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    A BREAK IN THE RETENTION DOME DURING TRACTION REMOVAL. THE INDWELL TIME WAS 212 DAYS. THE DOME PORTION WAS REMOVED ENDOSCOPICALLY USING GRASPING FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE, GASTROINTESTINAL (AND ACCESS) KNT C. R. BARD, INC. (BASD) HUTA1528

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention