BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA-MIX EMPTY EVA CONTAINER

    MDR report key: 1739598 · Received May 12, 2010

    Report

    Report Number
    1419106-2010-00010
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    March 22, 2010
    Report Date
    March 23, 2010
    Manufacturer
    BAXA CORPORATION
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY INFO FOR THIS PRODUCT PROBLEM REPORT IS UNK; THEREFORE, NO FURTHER FOLLOW-UP CAN BE PERFORMED. NO SAMPLE WAS RETURNED FOR INVESTIGATION FOR THIS COMPLAINT. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED LOT NUMBER. A REVIEW OF RISK DOCUMENTATION FOR THE REPORTED FAILURE WAS CONDUCTED AND IT WAS DETERMINED THAT THIS ISSUE IS NOT OCCURRING WITH GREATER FREQUENCY OR SEVERITY THAN ANTICIPATED FOR THE DEVICE. BAXA WILL CONTINUE TO MONITOR THIS TYPE OF REPORT TO DETERMINE IF CORRECTIVE ACTION IS INDICATED IN THE FUTURE.

    Description of Event or Problem · 1

    MEDWATCH (B)(4) DESCRIPTION: "BAXA EXACTA-MIX BAG WAS FILLED WITH TPN SOLUTION. LATER, IT WAS NOTED THAT A SMALL AMOUNT OF FLUID WAS COMING FROM THE BAG. IT WAS DETERMINED TO BE COMING FROM THE SIDE OF THE BAG THROUGH A BREACH IN THE SEAM." THIS MDR IS BEING FILED PER BAXA CORPORATION'S PROCEDURE TO SUBMIT AN MDR FOR ALL MEDWATCH FORMS SUBMITTED. THE COMPLAINT DATABASE WAS REVIEWED; A CUSTOMER COMPLAINT FOR THIS FAILURE WAS NOT RECEIVED BY BAXA PRIOR TO THIS REPORT. A COMPLAINT WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE, WHICH WAS RECEIVED BY BAXA ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX EMPTY EVA CONTAINER EXACTA-MIX EMPTY EVA CONTAINER LHI BAXA CORPORATION 739 744744

    Patients

    Seq Age Sex Outcome Treatment
    1