BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR

    MDR report key: 1932634 · Received December 19, 2010

    Report

    Report Number
    6000001-2010-06026
    Event Type
    Malfunction
    Date Received
    December 19, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED TWO USED SAMPLES FOR EVALUATION. BOTH SAMPLES ARRIVED OUT OF THE POUCH AND PRIMED. VISUAL INSPECTION SHOWED THAT THE BLUE HANGERS WERE NOT RETURNED. IT WAS ALSO NOTED THAT NO INTERLINK LEVER LOCK CANNULAS WERE RETURNED OR WERE ATTACHED TO THE MALE LUERS OF THE RETURNED SAMPLES. BOTH SAMPLES WERE SPIKED INTO A 1000 ML SOLUTION BAG CONTAINING REVERSE OSMOSIS WATER, RE-PRIMED, AND CHECKED FOR FLOW. BOTH RETURNED SAMPLES PRIMED AND FLOWED NORMALLY. THE ON-OFF CLAMP ON EACH SAMPLE FUNCTIONED AS DESIGNED WITH COMPLETE SHUTOFF NOTED. BECAUSE BOTH RETURNED SAMPLES PRIMED AND FLOWED NORMALLY, THE REPORTED CONDITION WAS NOT CONFIRMED AND THE ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE THAT THEY ARE HAVING PROBLEMS WITH THE CLEARLINK SECONDARY SET NOT RUNNING WHEN ATTACHED AS A PIGGYBACK. IT IS UNKNOWN WHEN THE CONDITION OCCURRED. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL SEC MED SET 35" W/LL&HANGERNO NEEDLE OR DISTAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1