BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXT SET

    MDR report key: 1942987 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06460
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K962581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. HOWEVER, A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THEIR BAXTER SALES REPRESENTATIVE (BSR) THAT AFTER SPIKING AN IV BAG WITH AN INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXTENSION SET THE SOLUTION WOULD NOT FLOW. IT IS UNKNOWN WHERE THE SOLUTION STOPS FLOWING. THE SETS ARE USED WITH LACTATED RINGERS. THE CONDITION OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 6 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK CONTINU-FLO 4-WAY STOPCOCK EXT SET STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO UR10D20032

    Patients

    Seq Age Sex Outcome Treatment
    1 LACTATED RINGERS