BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET BN310 W/O BP Y-CONNECTOR SET

    MDR report key: 7534173 · Received May 22, 2018

    Report

    Report Number
    2243072-2018-00293
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 9, 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 · 1

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO POSSIBLY BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2802092, MEDICAL DEVICE EXPIRATION DATE: 02/08/2021, DEVICE MANUFACTURE DATE: 02/27/2018. MEDICAL DEVICE LOT #: 2803121, MEDICAL DEVICE EXPIRATION DATE: 03/11/2021, DEVICE MANUFACTURE DATE: 03/21/2018. MEDICAL DEVICE LOT #: 2801043, MEDICAL DEVICE EXPIRATION DATE: 01/03/2021, DEVICE MANUFACTURE DATE: 01/18/2018. INVESTIGATION: ONE SAMPLE WAS RETURNED TO SBDM, THE LOT NUMBER IS UNKNOWN. REMARKS FROM COMPLAINT PIR INDICATE 3 POSSIBLE LOT FOR THIS SAMPLE: 2802092, 2803121, 2801043. HOUSE SAMPLE INSPECTION: SBDM CHECKED 10 PCS FOR EACH OF THE 3 POSSIBLE LOTS FOR THE COMPLAINT. NO FOREIGN MATTER WAS OBSERVED IN ALL 30 PCS. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 2802092, 2803121, 2801043. NO ABNORMALITY WAS OBSERVED. ROOT CAUSE: FROM 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 FORM 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. SBDMARE 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 2MONTHS IN OTHER MACHINES (INSTALLATION DATE: 8 TH 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. CONCLUSION: BASED ON INVESTIGATION, THE FM FROM COMPLAINT SAMPLE WAS OIL STAIN. 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 FORM 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER, DESCRIBED AS ¿OIL-LIKE¿, WAS SEEN ON THE SPIKE OF A BD IV SET (B)(4) W/O BP Y-CONNECTOR SET BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377724 BD¿ IV SET BN310 W/O BP Y-CONNECTOR SET IV ADMINISTRATION SET FPA BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other