BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET AN120 W/O BP

    MDR report key: 7719205 · Received July 25, 2018

    Report

    Report Number
    2243072-2018-00985
    Event Type
    Malfunction
    Date Received
    July 25, 2018
    Date of Event
    June 8, 2018
    Report Date
    August 27, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: YES. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER BEING 2801021. SBDM ANALYZED THE FM, INITIAL ASSESSMENT IS THE FOREIGN MATTER IS RUBBER, SIMILAR IN COLOR TO IV BAG RUBBER PORT. THE FM SIZE IS 5.017MM X 1.045MM. INFRARED SPECTROMETRY (IR) TEST: FROM THE IR ANALYSIS OF THE FOREIGN MATTER, THE RESULTS SHOW THE MATERIAL IS LATEX (RUBBER). DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 2801021, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT REVIEW: SBDM REVIEW CUSTOMER COMPLAINT RECORD, THERE IS NO SIMILAR ISSUE FOR SAME LOT FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATION, THE FOREIGN MATTER IS ANALYZED TO BE RUBBER MATERIAL BY INFRARED SPECTROMETRY TEST. THE LIKELY CAUSE FOR THE FOREIGN MATTER IS THAT RUBBER FRAGMENT WAS DETACHED FROM THE RUBBER PORT, WHEN THE USER HAD PIERCED THE SPIKE THROUGH THE RUBBER PORT. THE DETACHED RUBBER FRAGMENT SUBSEQUENTLY INFLOW INTO THE IV SET THROUGH THE INFUSION HOLE ON THE SPIKE. AS PER KOREAN STANDARD AND SPECIFICATION OF MEDICAL DEVICE, THE IV SET HAS A FILTER INSTALLED AT THE END OF LINE BEFORE THE ADAPTER RUBBER. SINCE THE FILTER SIZE IS 75 (200 MESH), THERE IS LITTLE POSSIBILITY THAT THE FM (SIZE 5.017MM X 1.045MM) CAN FLOW INTO HUMAN BODY. CORRECTIVE ACTIONS: SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET ASSEMBLY LINE WORKERS. SBDM IMPLEMENT TIGHTENED PRODUCT & PROCESS MANAGEMENT AND STRENGTHENING QUALITY INSPECTION FOR IV SET MANUFACTURING PROCESS. CONCLUSION: BASED ON INVESTIGATION, THE FOREIGN MATTER IS ANALYZED TO BE RUBBER MATERIAL BY INFRARED SPECTROMETRY TEST. THE LIKELY CAUSE FOR THE FM IS THAT RUBBER FRAGMENT WAS DETACHED FROM THE RUBBER PORT, WHEN THE USER HAD PIERCED THE SPIKE THROUGH THE RUBBER PORT. THE DETACHED RUBBER FRAGMENT SUBSEQUENTLY INFLOW INTO THE IV SET THROUGH THE INFUSION HOLE ON THE SPIKE. AS PER KOREAN STANDARD AND SPECIFICATION OF MEDICAL DEVICE, THE IV SET HAS A FILTER INSTALLED AT THE END OF LINE BEFORE THE ADAPTER RUBBER. SINCE THE FILTER SIZE IS 75 (200 MESH), THERE IS LITTLE POSSIBILITY THAT THE FM (SIZE 5.017MM X 1.045MM) CAN FLOW INTO HUMAN BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ IV SET AN120 W/O BP CONTAINED FOREIGN MATTER IN THE FLUID PATH. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ IV SET AN120 W/O BP CONTAINED FOREIGN MATTER IN THE FLUID PATH. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563206 BD¿ IV SET AN120 W/O BP IV TUBING FPA BECTON DICKINSON 2801021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other