BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL LEFT PRESOURCE CUSTOM KIT SCV561H19S

    MDR report key: 2973898 · Received February 13, 2013

    Report

    Report Number
    MW5029032
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 13, 2013
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CATH LAB PROCEDURE, A MERIT MANIFOLD SYRINGE MALFUNCTIONED RESULTING IN 10 ML OF AIR INJECTED INTO THE PT'S HEART. THIS REQUIRED MEDICAL INTERVENTION, INCLUDING CPR. THE PT WAS REVIVED AND STABILIZED. THE MERIT SYRINGE IS A COMPONENT IN A CUSTOM PROCEDURE KIT PRODUCED BY CARDINAL HEALTH 200, PRESOURCE PRODUCTS AND SERVICES, A CUSTOM PROCEDURE KIT COMPANY. LOCATED AT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64404 CARDINAL LEFT PRESOURCE CUSTOM KIT SCV561H19S MERIT MANIFOLD SYRINGE, A COMPANY IN KIT FMF 135054

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R