BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET BN311 W/O PUMP T-TYPE

    MDR report key: 7342947 · Received March 15, 2018

    Report

    Report Number
    2243072-2018-00105
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 20, 2018
    Report Date
    April 20, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    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

    SAMPLE WAS RETURNED TO SBDM FROM LOT NUMBER 2708242. THERE IS A BLACK FOREIGN MATTER IN THE CHAMBER. INFRARED (IR) SPECTROMETRY TEST WAS CONDUCTED TO ANALYZE THE FOREIGN MATTER. BASED ON THE INFRARED (IR) ANALYSIS RESULT, THE FM IS LIKELY PHTHALATE, 1 OF THE RAW MATERIAL COMPONENT OF THE CHAMBER. THE FM IS COMPLETELY MOLDED INTO THE CHAMBER. HOUSE SAMPLE INSPECTION - SBDM INSPECTED SAME LOT HOUSE SAMPLES, NO ISSUE WERE FOUND. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED MANUFACTURING RECORDS SUCH AS PROCESS INSPECTION, MOLDING, TEST, MANUFACTURING OF THE AFFECTED LOT, THERE WAS NO ISSUE FOUND. CORRECTIVE ACTION: HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR MOLD INJECTION LINE AND IV SET ASSEMBLY LINE WORKERS. IMPLEMENTING TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR MOLDING MFG. PROCESS. CHECKED INJECTION MOLDING MACHINE FOR CHAMBER COMPONENT AND COMPLETED CLEANING OF THE SCREW & AROUND THE PRODUCTION AREAS AND MADE ARRANGEMENT ON THEM. CLEANING FREQUENCY WAS CHANGED. OPERATE CHAMBER INJECTION MOLDING MACHINE ONLY AFTER MOLD CLEANING AND START NORMAL PRODUCTION AFTER 10-SHOT TEST RUNS. AFTER MOLD CLEANING, WE PRODUCE INITIAL 10 SHOTS AND SCRAP THEM ALL BECAUSE INITIAL 10 SHOTS HAVE HIGHER POSSIBILITY OF DEFECT. THEREFORE, WE SCRAP INITIAL 10 SHOTS EVEN IF THEY HAVE NO DEFECT UPON PARTS INSPECTION AND THEN START THE NORMAL PRODUCTION. ENHANCE IV SET INSPECTION PROCESS IN 2 STEPS TO PREVENT SAME CUSTOMER COMPLAINT CASE. (START FROM: (B)(6) 2017). BASED ON THE INVESTIGATION RESULT OF THE COMPLAINT CASE, THE FM IS PVC CARBIDE. THE LIKELY CAUSE IS THE LIKELY CAUSE IS THAT PVC CARBIDE GOT STUCK INTO THE COMPLAINT CHAMBER DURING MOLDING PROCESS DUE TO HIGH TEMPERATURE (170 - 190).

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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. 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 THERE WAS FOREIGN MATTER FOUND IN THE CHAMBER OF A BD¿ IV SET BN311 W/O PUMP T-TYPE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185821 BD¿ IV SET BN311 W/O PUMP T-TYPE INTRAVASCULAR ADMINISTRATION SET FOZ BECTON DICKINSON 2708242

    Patients

    Seq Age Sex Outcome Treatment
    1 Other