BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2983134 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04923
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 18, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS CUSTOMER REPORTED CONDITION OF "HOLE IN THE T-CONNECTOR EXTENSION" WAS CONFIRMED THROUGH A RETURNED SAMPLE EVALUATION. ONE USED SAMPLE AND ONE UNUSED UNITS WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE SAMPLE IDENTIFIED A CUT IN TUBING IN THE AREA CLOSE TO THE WINGED FEMALE LUER IN THE USED SAMPLE. THE SET PASSED FUNCTIONAL AND PRESSURE TESTING. AS A CUT WAS IDENTIFIED DURING VISUAL INSPECTION THIS ISSUE WILL BE CONFIRMED FOR THE USED SAMPLE. CAUSALITY WAS NOT ESTABLISHED AS PART OF THIS EVALUATION. A BATCH REVIEW WAS PERFORMED AND NO ISSUES OR DEVIATIONS WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE INTERLINK T-CON EXT SET/MICRO-BORE HAD A HOLE IN THE T-CONNECTOR EXTENSION AND THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) HAD TO BE RE-STARTED. THIS OCCURRED DURING INFUSION BUT BEFORE MEDICATION WAS DELIVERED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87560 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR12K09047

    Patients

    Seq Age Sex Outcome Treatment
    1