BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER CBC II CONSTA VAC

    MDR report key: 432436 · Received October 9, 2002

    Report

    Report Number
    MW1026956
    Event Type
    Malfunction
    Date Received
    October 9, 2002
    Date of Event
    October 25, 2002
    Report Date
    December 9, 2002
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UPON REMOVAL OF DRAIN, FRAGMENT OF DRAIN REMAINED IN PT. PT RETURNED TO OR FOR COMPLETE REMOVAL. TOLERATED PROCEDURE WELL AND WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER CBC II CONSTA VAC BLOOD CONSERVATION SYSTEM CAC STRYKER INSTRUMENTS 225-28-916 02100892

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other