BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, GASTROINTESTINAL (AND ACCESS)

    MDR report key: 1040205 · Received May 8, 2008

    Report

    Report Number
    2523003-2008-00077
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 11, 2008
    Report Date
    April 15, 2008
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    KNT
    PMA / PMN Number
    K915841
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF THE RETENTION DOME BEING "TOO HARD" DURING TRACTION REMOVAL IS INCONCLUSIVE. THE COMPLAINT INCIDENT COULD NOT BE REPLICATED IN THE LABORATORY SETTING. GROSS VISUAL MICROSCOPIC EXAMINATIONS AND TACTILE EXAMINATION SHOWED NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. THE COMPLAINT SAMPLE WAS COMPARED TO A NON-COMPLAINT SAMPLE AND SHOWED NO SIGNIFICANT DIFFERENCE IN THE SILICONE MATERIAL OF THE RETENSION DOMES. THE DOME THAT WAS RETURNED WAS STAINED YELLOW AND ENCRUSTED WITH RESIDUAL MATERIAL. A CHR IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFORMATION HAS BEEN PROVIDED BY THE COMPLAINT.

    Description of Event or Problem · 1

    TRACTION REMOVAL COULD NOT BE PERFORMED SINCE THE DOME WAS TOO HARD. THE INDWELLING PERIOD WAS 182 DAYS. THE USER CUT THE CATHETER AND REMOVED THE DOME ENDOSCOPICALLY.

    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