BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 LEAD EXTENSION SET W/0.22 MICRON AIR ELIMINATING

    MDR report key: 2072125 · Received April 28, 2011

    Report

    Report Number
    6000001-2011-03255
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K915390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS EVALUATED BY BAXTER. THE REPORTED CONDITION WAS CONFIRMED. ALL SETS ARE CHECKED FOR 100% CLEAR PASSAGE AND PRESSURE TESTED AT 8 PSI AS PART OF THE MANUFACTURING PROCESS, AND THE FILTER IS TESTED PREVIOUS TO ASSEMBLY IN THE SET. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS DEVICE IS SINGLE USE AND WILL BE DISCARDED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER'S QUALITY ENGINEER FROM (B)(4) REPORTED AN EXTENSION SET THAT FAILED A PRESSURE TEST AT 8PSI DUE TO A LEAKAGE AT THE AIR FILTER. THIS REPORTED CONDITION OCCURRED DURING SERVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 LEAD EXTENSION SET W/0.22 MICRON AIR ELIMINATING SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 FLOLINK LUER AND 2 CLEARLINK LUERS