BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1001364 · Received February 20, 2008

    Report

    Report Number
    1317056-2008-00010
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 25, 2008
    Report Date
    January 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE USED DEVICE HAS BEEN DISPOSED OF BY THE END USER HOSPITAL, AN INVESTIGATION WILL BE PERFORMED, INCLUDING A DEVICE HISTORY REVIEW AND A SCAR NOTIFICATION TO BE SENT TO BOSTON SCIENTIFIC'S 8CC SYRINGE SUPPLIER. UPON THE CONCLUSION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY CUSTOMER, WHEN PERFORMING A HAND INJECTION WITH AN 8CC SYRINGE, THE SYRINGE "BLEW OFF" THE MANIFOLD SPRAYING BLOODY CONTRAST MEDIA SOLUTION ON THE PHYSICIAN AND IN THE ROOM. THERE WAS NO HARM TO THE PATIENT. THE USED SYRINGE HAS BEEN DISPOSED OF AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC 8CC SYRINGE DXT BOSTON SCIENTIFIC NA 1238906

    Patients

    Seq Age Sex Outcome Treatment
    1