BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PERFUSION PACK

    MDR report key: 170794 · Received May 27, 1998

    Report

    Report Number
    1217435-1998-00115
    Event Type
    Malfunction
    Date Received
    May 27, 1998
    Date of Event
    May 10, 1998
    Report Date
    May 11, 1998
    Manufacturer
    TEXAS MEDICAL PROD.
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT AND EXAMINATION OF THE PACK, A PIN HOLE WAS NOTED IN THE STERILE DRAPING. THE UNIT WAS NOT USED. NO PT INVOLVEMENT OCCURRED. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PERFUSION PACK CUSTOM TUBE PACK DWF TEXAS MEDICAL PROD. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN