BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAEMOTRONIC

    MDR report key: 181643 · Received August 7, 1998

    Report

    Report Number
    2244060-1998-00008
    Event Type
    Malfunction
    Date Received
    August 7, 1998
    Date of Event
    June 9, 1998
    Report Date
    August 6, 1998
    Manufacturer
    HAEMOTRONIC, INC.
    Product Code
    BRZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LEAK OCCURRED IN CONNECTION BETWEEN VENOUS CHAMBER AND CAP. REF: 060998 - A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMOTRONIC BLOOD TUBING SET BRZ HAEMOTRONIC, INC. 50508/H2 B98-67

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other