BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3142676 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14085
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, COMPANION SAMPLES ARE AVAILABLE BUT HAVE NOT YET BEEN RECEIVED BY BAXTER. SHOULD ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. EVALUATION SUMMARY: TWO COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION, FUNCTIONAL TESTING, HYDRAULIC BURST TESTING AND FLOW TESTING WERE PERFORMED. THE DEVICES PASSED ALL TESTING; THE UNITS MET WITHIN THE SPECIFICATION REQUIREMENTS. THE CAUSE OF THE REPORTED MALFUNCTION WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CATHETER EXTENSION SET WITH ONE LINK NEEDLE FREE IV CONNECT EXPERIENCED A BACKFLOW OF BLOOD. THE REPORTER STATED THAT THE PATIENT WAS ATTACHED TO THE EXTENSION SET AND AFTER 45 MIN THE SET FILLED WITH BLOOD. THE EXTENSION SET WAS FLUSHED AND CONNECTIONS WERE SECURED PRIOR TO USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244931 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR13A07032

    Patients

    Seq Age Sex Outcome Treatment
    1