BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORP

    MDR report key: 673351 · Received October 21, 2005

    Report

    Report Number
    1317056-2005-00055
    Event Type
    Malfunction
    Date Received
    October 21, 2005
    Date of Event
    September 22, 2005
    Report Date
    September 22, 2005
    Manufacturer
    BOSTON SCIENTIFIC /NAMIC
    Product Code
    DTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HOSP IS REPORTEDLY EXPERIENCING ISSUES WITH THE RADIOLOGY CONTROL SYRINGES PACKAGED WITHIN THEIR CONVENIENCE KIT. SUPPOSEDLY THE SYRINGES ARE ALLOWING FOR THE ASPIRATION OF AIR BUBBLES. THERE HAS BEEN NO AIR INJECTION OR PT INJURY. NO SAMPLES ARE BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORP CONVENIENCE KIT DTL BOSTON SCIENTIFIC /NAMIC NA 1073008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN