BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CONTINU-FLO SOLN SET2 INJ SITES 10 DPM

    MDR report key: 2062672 · Received April 19, 2011

    Report

    Report Number
    6000001-2011-02962
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THE REPORTED CONDITION WAS CONFIRMED. THE SEPTUM WAS NOT FOUND IN THE SECOND INTERLINK Y-SITE. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. THIS FAILURE IS DIRECTLY RELATED WITH (B)(4). THE LOT REPORTED BY THE CUSTOMER WAS MANUFACTURED BEFORE THIS ACTION WAS IMPLEMENTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) THAT THERE WAS NO BUNG ON DISTAL INJECTION PORT ON THE INTERLINK CONTINU-FLO SOLUTION SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO SOLN SET2 INJ SITES 10 DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10H25099

    Patients

    Seq Age Sex Outcome Treatment
    1