BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3041369 · Received April 8, 2013

    Report

    Report Number
    1416980-2013-08727
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A J-TUBE WAS ATTACHED TO THE Y-SITE. THE CUSTOMER STATED THAT WHEN THE J-TUBE WAS DETACHED, AN UNKNOWN AMOUNT OF BLOOD WAS OBSERVED TO BE "SUCKED OUT OF THE Y-SITE". THE CUSTOMER ALSO NOTED THAT A PICC WAS ALSO IN USE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER INJECTABLE MICROBORE CATHETER EXTENSION SET WITH NEUTRAL LUER ACTIVATED DEVICES WAS OBSERVED TO BACKFLOW. DURING INFUSION, THE NURSE ATTACHED AN UNKNOWN SYRINGE TO THE LOWEST Y-SITE AND INJECTED AN UNKNOWN MEDICATION. AFTER COMPLETION OF THE INJECTION, THE SYRINGE WAS DETACHED FROM THE Y-SITE. BLOOD FROM THE PATIENT BACKED UP THROUGH THE EXTENSION SET INTO PART OF THE PRIMARY TUBING. THE BLOOD WAS FLUSHED OUT. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143360 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 JEJUNOSTOMY TUBE, PICC LINE| UNKNOWN SYRINGE, UNKNOWN PRIMARY SET| UNKNOWN MEDICATION