BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2772184 · Received October 4, 2012

    Report

    Report Number
    1416980-2012-01534
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF ONE CLEARLINK ADMINISTRATION SET THAT WAS ALLEGED TO HAVE A LOOSE CONNECTION ON THE UPSTREAM LUER CLOSEST TO THE MANIFOLD, WAS CONFIRMED; HOWEVER, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. A BATCH REVIEW WAS NOT CONDUCTED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. SHOULD ANY ADDITIONAL INFORMATION BE MADE AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO A BAXTER REPRESENTATIVE A CONDITION OF ONE CLEARLINK ADMINISTRATION SET THAT WAS ALLEGED TO HAVE A LOOSE CONNECTION ON THE UPSTREAM LUER CLOSEST TO THE MANIFOLD. THIS LUER WAS OBSERVED LOOSE BEFORE USE, AND WAS TIGHTENED BY THE FACILITY, BUT AGAIN CAME LOOSE DURING INFUSION ON AN UNKNOWN PATIENT. IT IS UNKNOWN WHAT SOLUTION WAS BEING INFUSED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1