BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-SIPHON PCA EXTENSION SET

    MDR report key: 1190019 · Received October 8, 2008

    Report

    Report Number
    6000001-2007-01266
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    January 5, 2007
    Report Date
    January 5, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JAN 11, 2007. THE REPORTED DEVICE HAS BEEN DISCARDED AND WILL NOT BE RETURNED FOR AN EVALUATION.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM FACILITY PHARMACY MANAGER. CUSTOMER REPORTS UPON USING THE BAXTER PCA SYRINGES AND THE SET, A LEAK WAS DETECTED AT THE HUB WHILE INFUSING MORPHINE. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-SIPHON PCA EXTENSION SET ANESTHESIA EXTENSION SET FPA BAXTER HEALTHCARE CORPORATION NA UR343798

    Patients

    Seq Age Sex Outcome Treatment
    1