BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3843847 · Received June 2, 2014

    Report

    Report Number
    1416980-2014-17671
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K130245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION NOTED A CRACK IN THE 4-WAY LARGE BORE 2 GANG STOPCOCK. FUNCTIONAL, CLEAR PASSAGE, AND PRESSURE TESTING WERE PERFORMED, WITH THE SAMPLE FAILING THE PRESSURE AND FUNCTIONAL TESTING DUE TO THE CRACK IN THE STOPCOCK. A LEAK WAS OBSERVED WHEN THE SET WAS HOOKED UP TO A PRESSURE GAUGE AT 8 PSI AND SUBMERGED UNDER WATER. THE LEAK WAS AGAIN OBSERVED WHEN THE SET WAS PRIMED WITH FLUID. THE CAUSE OF THE PROBLEM IS UNKNOWN. A CAPA HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER UR13J17058 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE EVALUATION IS IN PROGRESS, UPON COMPLETION OF BAXTER'S INVESTIGATION, IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION IT WAS DISCOVERED THAT A CLEARLINK SYSTEM CONTINU-FLO STOPCOCK EXTENSION SET HAD A CRACK IN THE FOUR-WAY LARGE BORE TWO GANG STOPCOCK. A LEAK WAS OBSERVED TO BE COMING FROM THE CRACK. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321674 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO UR13J17058

    Patients

    Seq Age Sex Outcome Treatment
    1