BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET,CLEARLINK, Y TYPE BLDW/CLAMP,LL,100IN

    MDR report key: 1791998 · Received August 10, 2010

    Report

    Report Number
    6000001-2010-02457
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - SHERBROOKE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS BEEN REQUESTED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED IF WHEN THE SAMPLE IS RETURNED AND EVALUATED OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE REVEALED A V-SHAPED CUT IN THE MIDDLE SECTION OF THE TUBING. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SMALL HOLE DEVELOPED. THE TUBING WAS USED WITH A COLLEAGUE VOLUMETRIC INFUSION PUMP, (B)(4). THE REPORTED CONDITION OCCURRED DURING USE WHEN BLOOD WAS NOTICED ON THE BED AND THE HOLE WAS FOUND. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET,CLEARLINK, Y TYPE BLDW/CLAMP,LL,100IN SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SHERBROOKE

    Patients

    Seq Age Sex Outcome Treatment
    1