BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 552484 · Received October 27, 2004

    Report

    Report Number
    1317056-2004-00041
    Event Type
    Other
    Date Received
    October 27, 2004
    Date of Event
    September 28, 2004
    Report Date
    September 28, 2004
    Manufacturer
    BOSTON SCIENTIFIC/NAMIC
    Product Code
    DTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSP USES A CONVENIENCE KIT. DURING AN ANGIOGRAPHIC PROCEDURE AIR WAS INJECTED INTO A PT. THERE WAS NO PT INJURY. THE CUSTOMER BELIEVES THAT THE ISSUE WAS DUE TO CRACKING AT THE SYRINGE CONNECTION PORT OF THE MANIFOLD PACKAGED IN THE KIT. THE DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CONVENIENCE KIT DTL BOSTON SCIENTIFIC/NAMIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other