BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE CARDIOPLEGIA CANNULA

    MDR report key: 83747 · Received April 8, 1997

    Report

    Report Number
    1713910-1997-00006
    Event Type
    Malfunction
    Date Received
    April 8, 1997
    Date of Event
    January 31, 1997
    Report Date
    April 7, 1997
    Manufacturer
    RESEARCH MEDICAL, INC.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON RECEIVING THE UNITS, THE DISTRIBUTOR'S SALES REP. DISCOVERED THERE WAS NO TIE BAND ON THE INFLATION LINE STOPCOCK. THE DISTRIBUTOR RETURNED ALL PRODUCT EXHIBITING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGRADE CARDIOPLEGIA CANNULA CARDIOPLEGIA CANNULA DWF RESEARCH MEDICAL, INC. N/A 87633

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other