BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET SN404 W/O BP Y-CONN

    MDR report key: 7526058 · Received May 18, 2018

    Report

    Report Number
    2243072-2018-00285
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Date of Event
    April 27, 2018
    Report Date
    June 7, 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

    ONE SAMPLE WAS RETURNED TO SBDM, THE LOT NUMBER IS 2710311. SBDM INSPECTED THE COMPLAINT SAMPLE, THERE WAS AN OIL STAIN ON THE TIP OF THE SPIKE. HOUSE SAMPLE INSPECTION: SBDM CHECKED 15 PCS FOR LOT 2710311, NO FOREIGN MATTER WAS OBSERVED. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 2710311. NO ABNORMALITY WAS OBSERVED. SBDM COMPLAINT REVIEW: SBDM REVIEW COMPLAINT RECORD FOR SAME PRODUCT LOT 2710311, THERE ARE NO REPEATED SAME ISSUE FROM OTHER CUSTOMERS. BASED ON THE INVESTIGATION THERE ARE 2 POSSIBLE CAUSES: DURING SPIKE MOLDING MANUFACTURING PROCESS, WHEN THE SPIKE COMPONENT IS INJECTED FROM THE SPIKE MOLD, IT MAY NOT BE DROPPED DOWNWARDS TO COLLECTION BIN IMMEDIATELY. THERE ARE CHANCES THE SPIKE MAY REMAIN STUCK IN THE INJECTION MACHINE AND GET CONTAMINATED BY OIL STAIN FROM THE TIE BAR. ANOTHER POSSIBILITY IS OIL FROM INJECTION MACHINE COULD BE DROPPED INTO THE PRODUCTS WHEN SUPPORTING MOLDING PARTS ARE MOVING ALONG THE BED OF INJECTION MACHINE. CORRECTIVE ACTIONS: SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR IV SET ASSEMBLY LINE AND INJECTION MOLDING LINE WORKERS. SBDM ARE IMPLEMENTING TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR IV SET MANUFACTURING PROCESS. SBDM COMPLETED MAINTENANCE REPAIR AND 5S FOR SPIKE MOLDING INJECTION MACHINE. INSTALL PVC GUARD ON THE TIE BAR TO PREVENT OIL DROP ON THE PRODUCTS FOR NON-VENTED SPIKE MACHINE AFTER TESTING FOR 2 MONTHS IN OTHER MACHINES (INSTALLATION DATE: 8TH MAY). 2018. SBDM WILL CHECK THE TIE BAR GUARD EVERY DAY AND WILL REPLACE EVERY MONTH. 5. INSTALL BED GUARD ON THE INJECTION MACHINE TO PREVENT OIL DROP ON THE PRODUCTS. SBDM HAS INTERNAL CAPA (B)(4) IN PLACE TO MONITOR THIS DEFECT TREND AND EFFECTIVENESS OF ACTIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD¿ IV SET SN (B)(4) W/O BP Y-CONN WAS FOUND WITH FOREIGN MATTER AS ¿SOMETHING BLACK ON THE IV SET SPIKE". THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370335 BD¿ IV SET SN404 W/O BP Y-CONN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2710311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other