BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN120 W/O BP

    MDR report key: 10519378 · Received September 11, 2020

    Report

    Report Number
    2243072-2020-01399
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 20, 2020
    Report Date
    September 25, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2003132. THERE IS A FM ON THE CHAMBER, INITIAL THOUGHTS WAS IT IS PVC CARBIDE AS OF THE RAW MATERIAL OF THE CHAMBER. INFRARED SPECTROMETRY (IR) TEST: BASED ON INFRARED SPECTROMETRY (IR) ANALYSIS OF THE COMPLAINT SAMPLE, THE FM IS SAME COMPONENT WITH RAW MATERIAL OF CHAMBER (POLYESTER). HOUSE SAMPLE INSPECTION: SBDM INSPECTED 30 HOUSE SAMPLES OF THE COMPLAINT PRODUCT FROM LOTS 2003111, 2003132 & 2003161, THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: CUSTOMER COMPLAINT RECORD REVIEW OF COMPLAINT SAMPLE: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS NO SIMILAR ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: FROM INVESTIGATION, THE IR RESULTS SHOWS THE FM IS SAME COMPONENT WITH RAW MATERIAL OF CHAMBER (POLYESTER). THE RAW MATERIAL OF THE CHAMBER COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE (200¿~240¿). IT IS LIKELY THAT PVC(RAW MATERIAL OF CHAMBER COMPONENT) CARBIDE MAY BE FORMED IN THE HIGH TEMPERATURE OR GAS EMISSION LINE ON THE INJECTION MOLD WAS BLOCKED TEMPORARY AND THE GAS FORMED CARBIDE. THEREFORE THE CARBIDE WAS INJECTED WITH THE CHAMBER OF THE COMPLAINT I.V SET WHILE INJECTION PROCESS. HOWEVER, THE PROCESS INSPECTOR DID NOT NOTICE IT WHILE MANUFACTURING PROCESS AND IT CAUSED THIS COMPLAINT CASE. CORRECTIVE ACTIONS: 1. HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR INJECTION MOLDING LINE WORKERS. 2. IMPLEMENTED TIGHTENED PRODUCT & PROCESS MONITORING AND STRENGTHENING QUALITY INSPECTION FOR MOLDING MANUFACTURING PROCESS. 3. CHECKED INJECTION MOLDING MACHINE FOR THE CHAMBER COMPONENT AND COMPLETED CLEANING OF THE SCREW & AROUND THE PRODUCTION AREAS AND MADE ARRANGEMENT ON THEM. ¿ CLEANING FREQUENCY: A. SCREW ¿ WEEKLY B. AROUND THE MOLDING MACHINE ¿ DAILY (TWICE A DAY & WHEN DAY-NIGHT SHIFT IS CHANGED) C. GENERAL CLEANING OF MOLDING LINE - EVERY WEEK (LAST OPERATION DAY OF THE WEEK, FOR 2HOUR. AFTER SHUTDOWN) 4. REVIEW INJECTION CONDITION OF THE CHAMBER COMPONENT (SPECIALLY GAS EMISSION LINE ON THE CHAMBER INJECTION MOLD) AND WE FOUND THAT THERE WAS NO GAS EMISSION LINE BLOCKAGE ISSUE. CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM. FROM INVESTIGATION, THE IR RESULTS SHOWS THE FM IS SAME COMPONENT WITH RAW MATERIAL OF CHAMBER (POLYESTER). THE RAW MATERIAL OF THE CHAMBER COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE (200¿~240¿). IT IS LIKELY THAT PVC(RAW MATERIAL OF CHAMBER COMPONENT) CARBIDE MAY BE FORMED IN THE HIGH TEMPERATURE OR GAS EMISSION LINE ON THE INJECTION MOLD WAS BLOCKED TEMPORARY AND THE GAS FORMED CARBIDE. THEREFORE THE CARBIDE WAS INJECTED WITH THE CHAMBER OF THE COMPLAINT I.V SET WHILE INJECTION PROCESS. HOWEVER, THE PROCESS INSPECTOR DID NOT NOTICE IT WHILE MANUFACTURING PROCESS AND IT CAUSED THIS COMPLAINT CASE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV SET AN120 W/O BP HAD FOREIGN MATTER IN IV SET CHAMBER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL IN IV SET CHAMBER. AFTER MIXING 100ML OF 0.9%N/S WITH MEROPENE, IT WAS CONNECTED TO IV SET AND PRIMED, AND FOREIGN MATERIAL WAS FOUND IN THE CHAMBER. IT WAS NOT USED ON PATIENTS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN (B)(4) 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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IV SET AN120 W/O BP HAD FOREIGN MATTER IN IV SET CHAMBER. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL IN IV SET CHAMBER. AFTER MIXING 100ML OF 0.9% N/S WITH MEROPENE, IT WAS CONNECTED TO IV SET AND PRIMED, AND FOREIGN MATERIAL WAS FOUND IN THE CHAMBER. IT WAS NOT USED ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990084 IV SET AN120 W/O BP INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 2003132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other