BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUPATH BIOPSY DEVICE

    MDR report key: 1222889 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06067
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    DURING THE BRONCHOSCOPY PROCEDURE OF THE RIGHT MAIN STEM, THE TRUPATH BIOPSY NEEDLE WAS USED. THE PHYSICIAN TRIED TO EJECT THE FLUID THAT HAD ALREADY ASPIRATED. THROUGH THE FLUID DID NOT COME OUT. SALIN LEAKED AT THE WRONG PLACE FROM THE SYRINGE. THE SUPERVISOR UNSCREWED THE SYRINGE AND PUT MORE SALINE IN AND TRIED TO INJECT THE MATERIAL INTO THE LAB CUP. IT STILL LEAKED. THE SAMPLE WAS LOST. THE DIFFERENT DEVICE WAS USED TO COMPLETE THE CASE. THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUPATH BIOPSY DEVICE FCG BOSTON SCIENTIFIC CORPORATION M00564121 11854974

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR