BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXACTA-MIX EMPTY EVA CONTAINER

    MDR report key: 1512828 · Received May 11, 2009

    Report

    Report Number
    1419106-2009-00010
    Event Type
    Malfunction
    Date Received
    May 11, 2009
    Date of Event
    June 9, 2008
    Report Date
    May 7, 2009
    Manufacturer
    BAXA CORP.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SUPPLIER WAS NOTIFIED OF THIS COMPLAINT ON (B)(6) 2008 AND 1 USED SAMPLE WAS SENT FOR EVAL. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND NO NCMRS WERE NOTED. QUALITY RECORDS INDICATED THAT ALL INSPECTIONS AND TESTS REQUIRED FOR THE AFFECTED LOT WERE PERFORMED ACCORDING TO RELEASED REVISIONS OF THE MFG ASSEMBLY, IN PROCESS INSPECTION, AND FINAL INSPECTION PROCEDURES, INCLUDING LEAK TESTING. THE SAMPLE WAS LEAK TESTED UNDERWATER USING AN AIR PRESSURE OF 5 PSI AND THE LEAKING FAILURE WAS CONFIRMED. VISUAL INSPECTION SHOWED THAT 1 HOLE PENETRATED THE BAG ON BOTH SIDES (LOCATED ON THE UPPER RIGHT SIDE FROM THE FRONT OF THE BAG) AND ANOTHER HOLE WAS IDENTIFIED ON THE BOTTOM RIGHT SIDE OF THE BAG PIERCING THE BACKSIDE ONLY. THE ROOT CAUSE FOR THIS COMPLAINT IS UNK; POSSIBLE ROOT CAUSES SUGGESTED INCLUDE EXTERNAL (NON-PROCESS RELATED) PIERCINGS. THE SUPPLIER INVESTIGATION TEAM INTENTIONALLY PIERCED BAGS USING A NEEDLE PIN AND OBTAINED PIERCINGS OF SIMILAR SHAPE AND SIZE; HOWEVER, THERE IS NOT ENOUGH INFO PROVIDED TO DETERMINE ROOT CAUSE. THE CUSTOMER WAS CONTACTED ON THREE SEPARATE OCCASIONS TO OBTAIN A COPY OF THE MEDWATCH REPORT FILED; HOWEVER, THE CUSTOMER DID NOT RESPOND TO THESE REQUESTS.

    Description of Event or Problem · 1

    THE MAUDE DATABASE WAS REVIEWED ON (B)(6) 2009 AND MEDWATCH REPORT NUMBER (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 EXAMINED FOR THE REPORTED DEVICE LOT NUMBER 830056 AND (B)(4) WAS IDENTIFIED WHEN (B)(4) WAS REPORTED ON (B)(6) 2008, ETH CUSTOMER DID NOT INDICATE ANY INTENTIONS TO SUBMIT A MEDWATCH AT THAT TIME. (B)(4) SHOWED NO PT INVOLVEMENT FOR THIS ISSUE. MEDWATCH EVENT DESCRIPTION: INTRAVENOUS PARENTERAL NUTRITION BAGS CONTAINED VERY SMALL LEAKS. THE LEAKS WERE IDENTIFIED BY SMALL INTERMITTENT DRIPPING OF THE PRODUCT WHEN THE BAG WAS SQUEEZED. NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA-MIX EMPTY EVA CONTAINER 1000 ML EVA BAG LHI BAXA CORP. 139 830056

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK