BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3081278 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10556
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K130245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, NO EVALUATION COULD BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK CONTINU-FLO SOLUTION SET WAS CRUSHED. IT IS UNKNOWN DURING WHAT PROCESS STEP THIS MALFUNCTION WAS IDENTIFIED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182486 ACCESS STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO UR12L11116

    Patients

    Seq Age Sex Outcome Treatment
    1