BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET BN306 W/O BP 200C

    MDR report key: 8782534 · Received July 11, 2019

    Report

    Report Number
    2243072-2019-01394
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 24, 2019
    Report Date
    June 26, 2019
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS GREATER ASIA. THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). INVESTIGATIONS: 1 SAMPLE WAS RETURNED TO (B)(4) , LOT NUMBER IS 2902112. FROM VISUAL INSPECTION, (B)(4) SUPPOSE THE FM IS ABS PARTICLE. INFRARED SPECTROMETRY ANALYSIS (IR): FROM IR ANALYSIS, THE FM IS DETERMINED TO BE ABS, RAW MATERIAL OF SPIKE. HOUSE SAMPLE INSPECTION: (B)(4) INSPECTED 30 PCS OF HOUSE SAMPLES FROM LOTS 2901182, 2902112, 2902151, NO ABNORMALITY OBSERVED. DHR REVIEW: (B)(4) REVIEWED THE MANUFACTURING RECORD, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: (B)(4) REVIEWED CUSTOMER COMPLAINT RECORD, THERE IS NO SAME ISSUE OF SAME PRODUCT FROM OTHER CUSTOMERS. ROOT CAUSE: FROM IR ANALYSIS, THE FM IS ABS PARTICLE. THE LIKELY CAUSE IS THE RAW MATERIAL OF I.V SET SPIKE COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE (200¿~240¿). HOWEVER, THE RUNNER OF SPIKE COMPONENT WAS NOT COOLING ENOUGH AT THAT TIME, AND THE RUNNER WAS NOT SOLIDIFIED ENOUGH WHEN THE RUNNER AND COMPONENTS WERE EJECTED. AS SUCH, THE RUNNER WAS NOT REMOVED CLEARLY AND THE MELTED PARTICLE OF RUNNER ATTACHED ON THE WALL OF MOLD AND CRUSHED IN THE NEXT INJECTION PROCESS. SUBSEQUENTLY, THE CRUSHED PARTICLE OF RUNNER WAS ATTACHED ON THE SPIKE COMPONENTS. THE PROCESS INSPECTOR FAILED TO NOTICED IT WHILE MANUFACTURING PROCESS AND IT CAUSED THIS COMPLAINT CASE. CORRECTIVE ACTIONS: (B)(4) CONDUCTED QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR INJECTION MOLDING LINE WORKERS. (B)(4) IMPLEMENTED TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR MOLDING MFG. PROCESS. (B)(4) CHECKED INJECTION MOLDING MACHINE FOR I.V SET END TIP 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 2 HOURS AFTER SHUTDOWN). (B)(4) REVIEW INJECTION CONDITION OF SPIKE COMPONENT (SPECIALLY COOLING TIME AND EJECTING PROCESS.) 3RD JUL AND FOUND THAT THERE WAS NO COOLING AND EJECTING ISSUE. CONCLUSION: 1 SAMPLE WAS RETURNED TO (B)(4). FROM IR ANALYSIS, THE FM IS ABS PARTICLE. THE LIKELY CAUSE IS THE RAW MATERIAL OF I.V SET SPIKE COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE (200~240). HOWEVER, THE RUNNER OF SPIKE COMPONENT WAS NOT COOLING ENOUGH AT THAT TIME, AND THE RUNNER WAS NOT SOLIDIFIED ENOUGH WHEN THE RUNNER AND COMPONENTS WERE EJECTED. AS SUCH, THE RUNNER WAS NOT REMOVED CLEARLY AND THE MELTED PARTICLE OF RUNNER ATTACHED ON THE WALL OF MOLD AND CRUSHED IN THE NEXT INJECTION PROCESS. SUBSEQUENTLY, THE CRUSHED PARTICLE OF RUNNER WAS ATTACHED ON THE SPIKE COMPONENTS. THE PROCESS INSPECTOR FAILED TO NOTICED IT WHILE MANUFACTURING PROCESS AND IT CAUSED THIS COMPLAINT CASE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE IV SET BN306 W/O BP 200C WAS FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: FOREIGN MATTER IN IV SET, LIKE A BUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575439 IV SET BN306 W/O BP 200C INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2902112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other