BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3914185 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21548
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K112893
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE USED DEVICE AND AN UNUSED COMPANION DEVICE OF THE SAME LOT WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION, UNDERWATER LEAK TESTING, CLEAR PASSAGE TESTING, AND SIMULATED USE TESTING WERE PERFORMED ON THE UNUSED COMPANION SAMPLE; NO NONCONFORMANCES WERE OBSERVED. VISUAL INSPECTION OF THE USED DEVICE NOTED DAMAGED TUBING. CLEAR PASSAGE TESTING WAS PERFORMED ON THE USED DEVICE WITH NO ISSUES FOUND. UNDERWATER LEAK TESTING AND SIMULATED USE TESTING WERE PERFORMED; BOTH TESTS IDENTIFIED A LEAK IN THE USED DEVICE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED 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 REPORTED LEAK OCCURRED DUE TO THE DAMAGED TUBING; HOWEVER, THE CAUSE OF THE DAMAGE WAS UNABLE TO BE DETERMINED. IN ORDER TO FURTHER INVESTIGATE THIS CONDITION, A CAPA WAS OPENED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CATHETER EXTENSION SET LEAKED DURING THE INFUSION OF ANTIBIOTICS. THE TUBING WAS NOTED TO BE ¿DAMAGED WHERE THE CLAMP IS ATTACHED.¿ THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR ADVERSE EVENT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391700 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR13125144

    Patients

    Seq Age Sex Outcome Treatment
    1