BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML 18G 1-1/2IN

    MDR report key: 9889677 · Received March 27, 2020

    Report

    Report Number
    2243072-2020-00509
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    March 9, 2020
    Report Date
    March 12, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382905900723
    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 · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. 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. INVESTIGATION SUMMARY: INVESTIGATIONS: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2001063. INFRARED SPECTROMETRY (IR) ANALYSIS: FROM IR TEST, THE FM IN THE SYRINGE IS CONFIRMED TO BE POLYPROPYLENE, THE SAME RAW MATERIAL OF PLUNGER. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 PCS OF HOUSE SAMPLES FROM LOTS 1912233, 1001063 AND 2002123, NO ABNORMALITY OBSERVED. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 2001063, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD, NO SAME ISSUE FROM OTHER CUSTOMER. ROOT CAUSE: FROM INVESTIGATIONS, THE PLUNGER COMPONENT IS MANUFACTURED AT VERY HIGH TEMPERATURE (200¿~220¿) IN MANUFACTURING PROCESS. THERE IS POSSIBILITY THAT BURR OF PLUNGER WAS MANUFACTURED BY TEMPORARY MALFUNCTION OF INJECTION PROCESS AND IT IS ATTACHED A MOLD AND GET INTO THE NEXT INJECTION PROCESS AGAIN. SO, CARBIDE BURR OF PP(RAW MATERIAL) MAY BE PLACE INNER PART OF PLUNGER DURING PLUNGER MANUFACTURING(INJECTION) PROCESS. CORRECTIVE ACTIONS: SBDM CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR INJECTION MOLDING LINE WORKERS. SBDM IMPLEMENTED TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR MOLDING MFG. PROCESS. SBDM CHECKED INJECTION MOLDING MACHINE FOR PLUNGER COMPONENT AND COMPLETED CLEANING OF THE SCREW & AROUND THE PRODUCTION AREAS AND MADE ARRANGEMENT ON THEM. CLEANING FREQUENCY: SCREW ¿ WEEKLY. AROUND THE MOLDING MACHINE ¿ DAILY (TWICE A DAY & WHEN DAY-NIGHT SHIFT IS CHANGED). GENERAL CLEANING OF MOLDING LINE - EVERY WEEK (LAST OPERATION DAY OF THE WEEK, FOR 2HOUR. AFTER SHUTDOWN). CONDUCT PROCESS INSPECTION EVERY 2HOURS IN INJECTION LINE ¿ IF THERE IS ANY SIGN OF ABNORMALITY, THE LINE WORKER CLEANS THE MOLD IMMEDIATELY. SBDM IMPLEMENTED 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND WE ALSO HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE. CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM. FROM IR TEST, THE FM IN THE SYRINGE IS CONFIRMED TO BE POLYPROPYLENE, THE SAME RAW MATERIAL OF PLUNGER. FROM INVESTIGATIONS, THE PLUNGER COMPONENT IS MANUFACTURED AT VERY HIGH TEMPERATURE (200¿~220¿) IN MANUFACTURING PROCESS. THERE IS POSSIBILITY THAT BURR OF PLUNGER WAS MANUFACTURED BY TEMPORARY MALFUNCTION OF INJECTION PROCESS AND IT IS ATTACHED A MOLD AND GET INTO THE NEXT INJECTION PROCESS AGAIN. SO, CARBIDE BURR OF PP(RAW MATERIAL) MAY BE PLACE INNER PART OF PLUNGER DURING PLUNGER MANUFACTURING(INJECTION) PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND DURING USE WITH A SYRINGE 20ML 18G 1-1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FOREIGN MATTER IN SYRINGE. - LOOKS LIKE A FILM PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353006 SYRINGE 20ML 18G 1-1/2IN SYRINGE FMF BECTON DICKINSON 2001063 00382905900723

    Patients

    Seq Age Sex Outcome Treatment
    1 Other