BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY CUSTOM PACK

    MDR report key: 3231138 · Received June 26, 2013

    Report

    Report Number
    3231138
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 26, 2013
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FLECKS OF UNIDENTIFIED MATERIAL FOUND IN THE LARGE BLUE BOWL AND LID CONTAINED IN THE PACK.SPECKS NOTICED PRIOR TO CASE START AND PACK WAS CONSIDERED CONTAMINATED. THE PACK WAS DISPOSED OF AND NOT USED FOR THE CASE. NEW PACK OPENED AND USED. NO PATIENT HARM OCCURRED.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291360 CORONARY CUSTOM PACK KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD AVID MEDICAL, INC. ORHS031-17 889927

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR