BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRASET 500100

    MDR report key: 99365 · Received June 20, 1997

    Report

    Report Number
    MW1011534
    Event Type
    Malfunction
    Date Received
    June 20, 1997
    Date of Event
    June 11, 1997
    Report Date
    June 11, 1997
    Manufacturer
    SABRATEK CORP.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HAVE HAD NUMEROUS C/O OF LEAKING PROBLEM WITH SABRE SETS AT THE VENTING CUPS WHEN BEING SPIKED. SETS ARE "MADE IN CHINA". SETS "MADE IN SPAIN" ARE NOT A PROBLEM. THIS INCIDENT KEEPS REPEATING ITSELF. THIS HAS BEEN EVALUATED FOR 4-6 WEEKS AT LEAST.

    Description of Event or Problem · 2

    HAVE HAD NUMEROUS C/O OF LEAKING PROBLEM WITH SABRE SETS AT THE VENTING CUPS WHEN BEING SPIKED. SETS ARE "MADE IN CHINA" SETS "MADE IN SPAIN" ARE NOT A PROBLEM. THIS INCIDENT KEEPS REPEATING IT SELF. THIS HAS BEEN EVALUATED FOR 4-6 WEEKS AT LEAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRASET 500100 IV ADMINISTRATION SET FPA SABRATEK CORP. * 960726

    Patients

    Seq Age Sex Outcome Treatment
    1 * SETS USED ONLY FOR SABRETEK 3030 PUMP
    2 * SETS USED ONLY FOR SABRETEK 3030 PUMP