BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP.

    MDR report key: 678849 · Received November 9, 2005

    Report

    Report Number
    1317056-2005-00061
    Event Type
    Malfunction
    Date Received
    November 9, 2005
    Date of Event
    October 13, 2005
    Report Date
    October 13, 2005
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY HOSPITAL, THERE WAS A CRACK IN THE ROTATING ADAPTOR OF A THREE-VALVE MANIFOLD WHICH ALLOWED AIR TO GET INTO THE SYSTEM DURING ASPIRATIONS. THERE WAS NO PT INJURY. A SAMPLE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP. 3-VALVE MANIFOLD DTL BOSTON SCIENTIFIC/NAMIC NA 1068691

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN