BEUDAMED
    FDA Adverse Event Injury Summary report: N

    89-1714 ANGIO VALUE SET

    MDR report key: 277739 · Received May 12, 2000

    Report

    Report Number
    1034876-2000-00003
    Event Type
    Injury
    Date Received
    May 12, 2000
    Date of Event
    January 9, 2000
    Report Date
    May 4, 2000
    Manufacturer
    DEROYAL INDUSTRIES
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE CONTRAST SYRINGE DID NOT SEAT PROPERLY ON MANIFOLD, POSSIBLY ALLOWING AIR TO ENTER SYSTEM. CUSTOMER ALLEGES THAT AIR BUBBLES WERE INADVERTENTLY INJECTED INTO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 89-1714 ANGIO VALUE SET CBT MANAGED CHOICE BASIN CATH-LAB DQO DEROYAL INDUSTRIES 2 432374

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other