BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE

    MDR report key: 1193348 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05130
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    PMA / PMN Number
    K040018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVAL WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING A TRANSBRONCHIAL ASPIRATION PROCEDURE, THE EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE DID NOT ASPIRATE. THE DEVICE WAS PREPARED FOR THE PROCEDURE IN THE CORRECT WAY, BUT WHILE TRYING TO ASPIRATE, THE PHYSICIAN NOTICED THAT THERE DID NOT SEEM TO BE ANY SUCTION ON THE SYRINGE. A SECOND EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE WAS TRIED, IT ALSO HAD NO SUCTION. A THIRD EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED TO COMPLETE THE PROCEDURE. PATIENT'S STATUS WAS REPORTED AS "STABLE". NOTE: THIS COMPLAINT IS FOR ONE OF TWO DEVICES. PLEASE REFER TO MFR# 3005099803-2008-05131 FOR RELATED REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE EOQ BOSTON SCIENTIFIC CORPORATION M00564121 9696894

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK