BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACISTCVI MULTI-USE SYRINGE KIT

    MDR report key: 3522264 · Received September 24, 2013

    Report

    Report Number
    3522264
    Event Type
    Malfunction
    Date Received
    September 24, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBING CAME APART AT TUBING JUNCTION. A NEW SYRINGE WAS OPENED AND UTILIZED WITHOUT INCIDENT. IT IS UNKNOWN IF THE NEW SYRINGE KIT WAS OF THE SAME OR DIFFERENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482783 ACISTCVI MULTI-USE SYRINGE KIT INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS A2000 11513U

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR