BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET,CLEARLINK CONTINU-FLO 3YLL 106 IN 10DPM 48 EA/CA

    MDR report key: 1994067 · Received February 16, 2011

    Report

    Report Number
    6000001-2011-01079
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. THE BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT CONTAIN A U.S. 510K NUMBER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A CLEARLINK SET IN WHICH A NURSE STATED THAT SHE WAS UNABLE TO USE THE A VALVE ON THE CLEARLINK SET TO GIVE A MEDICATION. THE PROCESS STEP WAS DURING USE ON PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET,CLEARLINK CONTINU-FLO 3YLL 106 IN 10DPM 48 EA/CA SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE

    Patients

    Seq Age Sex Outcome Treatment
    1