BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET SN404 W/O BP Y-CONN

    MDR report key: 8206829 · Received December 31, 2018

    Report

    Report Number
    2243072-2018-01901
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    December 14, 2018
    Report Date
    January 10, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2810022. SBDM NOTICED BLACK FOREIGN MATTER (FM) IN THE CHAMBER. SBDM ANALYZED THE FM, DIMENSION BEING 1.162MM X 0.735MM, AND POTENTIALLY COULD BE PVC CARBIDE, WHICH IS RAW MATERIAL OF CHAMBER. INFRARED SPECTROMETRY (IR) ANALYSIS: SBDM ANALYZE THE FM USING IR. FROM THE IR RESULTS, THE FM IS DETERMINE TO BE THE SAME AS RAW MATERIAL OF CHAMBER. HOUSE INSPECTION: SBDM INSPECTED 15 PCS FROM HOUSE SAMPLE OF LOT 2810022, NO FM WAS OBSERVED. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 2810022, NO ABNORMALITY WAS OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED CUSTOMER COMPLAINT RECORD, THERE ARE NO SAME ISSUE FOR SAME PRODUCT FROM OTHER CUSTOMERS. ROOT CAUSE: FROM INVESTIGATION, THE BLACK FM IS DETERMINE TO BE PVC CARBIDE USING INFRARED SPECTROMETRY ANALYSIS, WHICH IS THE RAW MATERIAL OF CHAMBER. THE LIKELY CAUSES ARE THAT FM MAY BE INDUCED DURING MOLD INJECTION PROCESS OF CHAMBER, THE CARBIDE BEING FORMED DUE TO HIGH TEMPERATURE (170¿~190¿) IN MOLDING PROCESS. THE RAW MATERIAL IS MELTED IN A CYLINDER OF INJECTION MACHINE WITH HIGH TEMPERATURE, THE MELTED RAW MATERIAL IS PUSHED BY SCREW INTO THE MOLD. IN THIS PROCESS, IT IS POSSIBLE THAT THE MELTED RAW MATERIAL COULD BE STUCK ON THE DAMAGED OR WORN TIP OF SCREW, SUBSEQUENTLY, THE STUCK RAW MATERIAL COULD BE INJECTED INTO THE CHAMBER. CORRECTIVE ACTIONS: 1. SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR MOLD INJECTION LINE AND IV SET ASSEMBLY LINE WORKERS. 2. SBDM CONDUCT CLEANING MANUFACTURING LINE, INSPECTION TABLE AND ASSEMBLY TABLE 3 TIME A DAY, BEFORE START WORK, BEFORE LUNCH AND AFTER FINISH WORK, ACCORDING TO WORKING PLACE CLEAN PROCEDURE. 3. SBDM ENHANCED INSPECTION WHILE INJECTION PROCESS. SBDM ALSO PREPARE SPARE PART OF SCREW TIP TO EXCHANGE THE PART WHEN CARBIDE IS FOUND DURING INSPECTION OF CHAMBERS IN THE INJECTION PROCESS. SBDM WILL MAINTAIN THE SCREW TIP WHICH IS THAT THE CARBIDE IS MADE AS SPARE PART OF THE SCREW TIP AGAIN. 4. SBDM ENHANCE I.V SET INSPECTION PROCESS IN 3 STEPS TO PREVENT SAME CUSTOMER COMPLAINT CASE. 5. SBDM WILL CLEAR ALL RAW MATERIAL IN A CYLINDER OF THE CHAMBER INJECTION MACHINE AND CHECK INSIDE OF THE CYLINDER UNTIL 31ST JAN. 2019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ IV SET SN404 W/O BP Y-CONN HAD FOREIGN MATTER IN THE TUBE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ IV SET SN404 W/O BP Y-CONN HAD FOREIGN MATTER IN THE TUBE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045148 BD¿ IV SET SN404 W/O BP Y-CONN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2810022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other