BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD/SOLUTION CONTINU-FLO SETW/INTERLINK INJ SITE/NON-RETUR

    MDR report key: 1871778 · Received October 16, 2010

    Report

    Report Number
    6000001-2010-04089
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (U.S.); THEREFORE, IT DOES NOT HAVE A U.S. 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF FOREIGN MATTER INSIDE THE TUBING CAUSING LEAKING AND INABILITY TO USE TUBING. THE REPORTED CONDITION OCCURRED DURING USE. NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED. THIS IS REPORT 2 OF 2 RECEIVED WITH THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD/SOLUTION CONTINU-FLO SETW/INTERLINK INJ SITE/NON-RETUR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR10D09043

    Patients

    Seq Age Sex Outcome Treatment
    1