BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOOD SET 4MM

    MDR report key: 1873212 · Received October 18, 2010

    Report

    Report Number
    6000001-2010-04200
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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. EVALUATION SUMMARY: THE REPORTED CONDITION OF A 4MM BLOOD SET WHICH WAS FOUND TO HAVE GREASE INSIDE ITS DRIP CHAMBER WAS CONFIRMED DURING PRODUCT EVALUATION AS THE DRIP CHAMBER'S PLASTIC MATERIAL BEING CLOUDY. THIS CONDITION WAS CAUSED BY A MIGRATION OF STEARATE, ONE OF THE CONSTITUENTS OF THE PLASTIC MATERIAL COMPRISING THE SET. THIS DEVICE IS A SINGLE USE DEVICE AND WILL BE DISCARDED. A BATCH REVIEW WAS PERFORMED FINDING THAT NO EXCEPTION/NON-CONFORMANCE REPORTS WERE DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A 4MM BLOOD SET WAS FOUND TO HAVE GREASE INSIDE ITS DRIP CHAMBER, THEREBY CONTAMINATING THE STERILE FLUID PATH. THIS CONDITION WAS DISCOVERED BEFORE USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE. TEN 4MM BLOOD SETS, ALL LOT # 08C22V792, WERE REPORTED TO HAVE GREASE IN THEIR DRIP CHAMBERS. THIS MEDWATCH IS FOR SET 1 OF 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOOD SET 4MM SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 08C22V792

    Patients

    Seq Age Sex Outcome Treatment
    1