BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA-MIX EMPTY EVA CONTAINER

    MDR report key: 1719472 · Received April 2, 2010

    Report

    Report Number
    1419106-2010-00005
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 14, 2010
    Manufacturer
    BAXA CORP.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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. SUBSEQUENT TO THE MANUFACTURE OF THIS LOT, SEVERAL MFG CORRECTIONS WERE IMPLEMENTED DUE TO A PRODUCT RECALL IN (B)(6) 2009. THE PRODUCT MUST PASS (B)(4) TESTING AND BAXA DEFINED TESTING FOR DROP TEST RESISTANCE. 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

    THE MAUDE DATABASE WAS REVIEWED ON (B)(6) 2010 AND MEDWATCH (B)(4) WAS DISCOVERED. 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. REPORTED LOT NUMBER 739048 IS FOR OUR 2 L BAGS (B)(4), NOT (B)(4) AS REPORTED. MEDWATCH (B)(4) DESCRIPTION: "WE'VE HAD 4 INCIDENTS OF LEAKING IV-ADMIXED PREPARATIONS MADE IN 2 LITER BAXA EXACTA-MIX EVA CONTAINERS - REF: (B)(4)-EMPTY IV BAGS. ALL LEAKS WERE ALONG THE SIDE SEAM OF THE BAGS. NO PATIENTS RECEIVED ANY OF THESE BAGS SINCE THEY WERE DISCOVERED PRIOR TO SENDING TO THE HOSPITAL FLOOR. BAXA RECENTLY BEGAN IN-SOURCING THE MFG OF THESE BAGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX EMPTY EVA CONTAINER EXACTA-MIX EMPTY EVA CONTAINER KPE BAXA CORP. 740 739048

    Patients

    Seq Age Sex Outcome Treatment
    1