BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET

    MDR report key: 7534020 · Received May 22, 2018

    Report

    Report Number
    2243072-2018-00295
    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

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS SBDM. THIS SITE IS AN OEM MANUFACTURING SITE. 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. DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE "POSSIBLE" LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2801311 MEDICAL DEVICE EXPIRATION DATE: 01/30/2021 DEVICE MANUFACTURE DATE: 01/31/2018 MEDICAL DEVICE LOT #: 2802071 MEDICAL DEVICE EXPIRATION DATE: 02/06/2021 DEVICE MANUFACTURE DATE: 02/07/2018 MEDICAL DEVICE LOT #: 2712041 MEDICAL DEVICE EXPIRATION DATE: 12/03/2020 DEVICE MANUFACTURE DATE: 12/04/2017 MEDICAL DEVICE LOT #: 2801081 MEDICAL DEVICE EXPIRATION DATE: 01/07/2021 DEVICE MANUFACTURE DATE: 01/08/2018 MEDICAL DEVICE LOT #: 2709251 MEDICAL DEVICE EXPIRATION DATE: 09/24/2020 DEVICE MANUFACTURE DATE: 09/25/2017 INVESTIGATION: ONE SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS UNKNOWN. COMPLAINT SAMPLE INFRA-RED (IR) TEST: SBDM ANALYZED THE FOREIGN MATTER (FM) USING INFRARED SPECTROMETRY EQUIPMENT. THE FM IS DETERMINED TO BE POLYURETHANE CARBIDE. HOUSE SAMPLE VERIFICATION: SBDM INSPECTED HOUSE SAMPLE OF 5 POSSIBLE LOTS LISTED IN THE PIR, THERE IS NO SIMILAR FOREIGN MATTER FOUND. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORDS SUCH AS PROCESS INSPECTION REPORT, TEST REPORT, MOLDING MANUFACTURING RECORDS/ INSPECTION RECORDS OF THE RECEIVED COMPLAINT SAMPLE, THERE WAS NO ABNORMALITY ON THE MANUFACTURING RECORDS. ROOT CAUSE: THE LIKELY CAUSE IS: THE CHAMBER IS INJECTED IN THE MOLD AT HIGH TEMPERATURE (170 - 190). PVC(RAW MATERIAL OF CHAMBER) CARBIDE MAY BE FORMED IN THE HIGH TEMPERATURE AND IT WAS STUCK INTO THE COMPLAINT CHAMBER WHILE MOLDING PROCESS. THE MOST LIKELY CAUSE OF THIS CARBIDE IS: AS RAW PALLETS MELT IN THE CYLINDER OF INJECTION MACHINE WITH HIGH TEMPERATURE, THE MELTED MATERIAL IS PUSHED TO THE MOLD BY SCREW. THERE IS POSSIBILITY THAT THE MELTED RAW MATERIAL COULD BE STUCK ON THE DAMAGED OR WORN TIP OF SCREW. AFTER THAT THE STUCK RAW MATERIAL COULD BE INJECTED INTO THE CHAMBER. CORRECTIVE ACTIONS: SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR MOLD INJECTION LINE AND IV SET ASSEMBLY LINE WORKERS. 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. SBDM ENHANCED INSPECTION WHILE INJECTION PROCESS. TECHNICIAN WILL PREPARE SPARE PART OF SCREW TIP TO EXCHANGE THE PART WHEN THEY FIND CARBIDE WHILE INSPECTING A CHAMBER IN THE INJECTION PROCESS. ALSO, SBDM WILL MAINTAIN THE SCREW TIP WHICH IS THAT THE CARBIDE IS MADE AS SPARE PART OF THE SCREW TIP AGAIN. SBDM ENHANCE I.V SET INSPECTION PROCESS IN 3 STEPS TO PREVENT SAME CUSTOMER COMPLAINT CASE. CONCLUSION: BASED ON INVESTIGATION RESULT OF THE COMPLAINT CASE, THE FM IS CARBIDE OF RAW MATERIAL AND IT LIKELY OCCURRED DURING MOLD INJECTION PROCESS OF CHAMBER. AS RAW PALLETS MELT IN THE CYLINDER OF INJECTION MACHINE WITH HIGH TEMPERATURE, THE MELTED MATERIAL IS PUSHED TO THE MOLD BY SCREW. THERE IS POSSIBILITY THAT THE MELTED RAW MATERIAL COULD BE STUCK ON THE DAMAGED OR WORN TIP OF SCREW. AFTER THAT THE STUCK RAW MATERIAL COULD BE INJECTED INTO THE CHAMBER. BDM HAVE INTERNAL CAPA-18-047 IN PLACE TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD¿ IV SET. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377489 BD¿ IV SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other