BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B.BRAUN

    MDR report key: 8233212 · Received January 10, 2019

    Report

    Report Number
    2523676-2018-00113
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    August 27, 2018
    Report Date
    January 31, 2019
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    LHI
    UDI-DI
    04046964656101
    PMA / PMN Number
    K151423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ALTHOUGH THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION, HOUSE RETAIN SAMPLES FROM THE SAME BATCH WERE EVALUATED. VISUAL EXAMINATION OF THE RETAINS NOTED NO VISUAL DEFECTS. THE RETAINS WERE OCCLUSION TESTED AND VACUUM LEAK TESTED PER SPECIFICATIONS WITH PASSING RESULTS. THE RETAIN SAMPLES MET ALL SPECIFICATIONS. THE ORIGINAL REPORT FOR THIS INCIDENT WAS FILED AGAINST ITEM NUMBER 2112529, MANUFACTURER REPORT NUMBER 9681240-2018-00012. DURING THE INVESTIGATION FOR ITEM 2112529, AN FT-IR ANALYSIS WAS PERFORMED WHICH DETERMINED THAT THE PARTICULATE WAS POLYCARBONATE. AN ANALYSIS OF ALL COMPONENTS USED IN THE APEX COMPOUNDING SYSTEM (SOLUTION BAG TO FINAL CONTAINER) HAS DETERMINED THAT THERE ARE TWO COMPONENTS WITHIN THE SYSTEM THAT CONTAIN MATERIALS OF POLYCARBONATE; ONE IS THE APEX MANIFOLD M8701700, WHICH IS COMPRISED OF A BAYER MAKROLON 2558 NATURAL POLYCARBONATE AND THE OTHER IS THE APEX STRAIN RELIEF BAR M8751701, WHICH IS COMPRISED OF BAYER MAKROLON 2558 WHITE. SINCE THE STRAIN RELIEF BAR M8751701 IS ASSEMBLED TO THE OUTSIDE OF THE TRANSFER SET DURING FINAL ASSEMBLY, THERE IS VERY LITTLE POSSIBILITY OF ANY MATERIAL FROM THE STRAIN RELIEF BAR TO ENTERING THE FLUID PATH AND LEADING TO CONTAMINATION, THEREFORE OUR MAIN FOCUS WILL BE ON THE INVESTIGATION OF THE POLYCARBONATE MANIFOLD. AS OF 12.DEC.2018 THE FOLLOWING ACTIONS HAVE BEEN TAKEN IN RESPONSE TO THIS COMPLAINT: 1. INCREASED INCOMING INSPECTION PLAN OF MANIFOLD ITEM #M8701700. THIS ITEM WILL REMAIN AT THE INCREASED INSPECTION PLAN FOR THE NEXT 10 LOTS RECEIVED. 2. DISTRIBUTED A QUALITY ALERT TO THE INCOMING INSPECTION TEAM AS HEIGHTENED AWARENESS TO THE REPORTED DEFECT. 3. CONDUCTING ETR(JBIL-B6YSPG) TO MONITOR THE AMOUNT OF MANIFOLDS REJECTED IN-PROCESS DUE TO FOREIGN MATERIAL. MONITORING PERIOD WILL LAST FOR 10 SHIFT OF PRODUCTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE ORIGINAL REPORT FOR THIS INCIDENT WAS FILED AGAINST ITEM NUMBER 2112529, MANUFACTURER REPORT NUMBER 9681240-2018-00012. DURING THE INVESTIGATION FOR ITEM 2112529, AN FT-IR ANALYSIS WAS PERFORMED WHICH DETERMINED THAT THE PARTICULATE WAS POLYCARBONATE. AN ANALYSIS OF ALL COMPONENTS USED IN THE APEX COMPOUNDING SYSTEM (SOLUTION BAG TO FINAL CONTAINER) HAS DETERMINED THAT THERE ARE TWO COMPONENTS WITHIN THE SYSTEM THAT CONTAIN MATERIALS OF POLYCARBONATE; ONE IS THE APEX MANIFOLD M8701700, WHICH IS COMPRISED OF A BAYER MAKROLON 2558 NATURAL POLYCARBONATE AND THE OTHER IS THE APEX STRAIN RELIEF BAR M8751701, WHICH IS COMPRISED OF BAYER MAKROLON 2558 WHITE. SINCE THE STRAIN RELIEF BAR M8751701 IS ASSEMBLED TO THE OUTSIDE OF THE TRANSFER SET DURING FINAL ASSEMBLY, THERE IS VERY LITTLE POSSIBILITY OF ANY MATERIAL FROM THE STRAIN RELIEF BAR TO ENTERING THE FLUID PATH AND LEADING TO CONTAMINATION, THEREFORE OUR MAIN FOCUS WILL BE ON THE INVESTIGATION OF THE POLYCARBONATE MANIFOLD. AS OF 12.DEC.2018 THE FOLLOWING ACTIONS HAVE BEEN TAKEN IN RESPONSE TO THIS COMPLAINT: 1. INCREASED INCOMING INSPECTION PLAN OF MANIFOLD ITEM #M8701700. THIS ITEM WILL REMAIN AT THE INCREASED INSPECTION PLAN FOR THE NEXT 10 LOTS RECEIVED. 2. DISTRIBUTED A QUALITY ALERT TO THE INCOMING INSPECTION TEAM AS HEIGHTENED AWARENESS TO THE REPORTED DEFECT. 3. CONDUCTING ETR(JBIL-B6YSPG) TO MONITOR THE AMOUNT OF MANIFOLDS REJECTED IN-PROCESS DUE TO FOREIGN MATERIAL. MONITORING PERIOD WILL LAST FOR 10 SHIFT OF PRODUCTION. THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: AFTER FILING, DURING FINAL INSPECTION, WE FOUND A SMALL WHITE FLOATER IN THE BAG. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25692 B.BRAUN SET, I.V. FLUID TRANSFER LHI B. BRAUN MEDICAL INC. 0061629009 04046964656101

    Patients

    Seq Age Sex Outcome Treatment
    1