BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET TUR Y-TUBE

    MDR report key: 10131367 · Received June 8, 2020

    Report

    Report Number
    2243072-2020-00896
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 8, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON:(B)(6) 2020 H.6. INVESTIGATION: INVESTIGATIONS: 2 SAMPLES WERE RETURNED TO SBDM, LOT NUMBER IS 6002201. VISUAL INSPECTION: SBDM CHECKED THE COMPLAINT SAMPLES, THERE IS UNFORMED PINCH CLAMP, LIKELY OCCURRED DURING INJECTION PROCESS. WHEN INJECTION PROCESS WAS STARTED THE CONDITION OF THE PROCESS WAS NOT PROPER TEMPORARILY. UNFORMED PINCH CLAMP LOCK TEST: SBDM TEST THE PINCH CLAMP AFTER PUSH FOR 2 SECONDS, THE PINCH CLAMP IS LOCKED EVEN IT IS NOT PROPERLY FORMED IN INJECTION PROCESS. HOUSE SAMPLE INSPECTION: SBDM INSPECTED 15 PCS FROM LOT 6002031, 6002201 AND 6003051, ALL COMPONENTS ARE PROPERLY FORMED ON THE HOUSE SAMPLES. DHR REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD FOR LOT 6002201, NO ABNORMALITY OBSERVED. IN ADDITION, SBDM INSPECTED 30 INJECTION SHOTS OF CURRENT CLAMP INJECTION COMPONENTS AND THERE WAS NO ISSUE FOR ALL. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE WAS SIMILAR COMPLAINTS FROM OTHER CUSTOMERS. ROOT CAUSE: 2 SAMPLES WAS RETURNED TO SBDM. BASED ON THE INVESTIGATION RESULT, THE LIKELY CAUSE MAY BE OCCURRED DURING CLAMP INJECTION PROCESS. ACCORDING TO THE INVESTIGATION BY RECEIVED COMPLAINT SAMPLES, THE CAVITY NUMBER OF UNFORMED CLAMPS IS CAVITY NO.2. IT IS LIKELY THERE WOULD BE RAW MATERIAL POWDER STOCK PROBLEM ON THE CAVITY NO.2.. THE CLAMP IS INJECTED IN HIGH TEMPERATURE (200¿~240¿) AND INJECTION GAS WAS NOT EMITTED PROPERLY SO, THE GAS WAS ACCUMULATED IN THE END POINT OF CLAMP AND IT CAUSED THE COMPLAINT CASE. ANOTHER POSSIBILITY IS WHEN INJECTION PROCESS WAS STARTED THE CONDITION OF THE PROCESS WAS NOT PROPER TEMPORALLY, CAUSING THE UNFORMED CLAMP ISSUE. CORRECTIVE ACTIONS: 1. CONDUCT QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR INJECTION MOLDING WORKERS. 2. MAINTAIN A PINCH CLAMP MOLD AS 5S. 3. ENHANCE MONITORING OF THE PROCESS AND INSPECTION. 4. SCRAP INITIAL 10 SHOTS (TEST RUN) OF SPIKES AFTER CLEANING THE MOLD OR INJECTION MOLDING MACHINE EVEN IF THEY HAVE NO DEFECT UPON PARTS INSPECTION AND THEN START THE NORMAL PRODUCTION. THIS IS BECAUSE INITIAL 10 SHOTS HAVE HIGHER POSSIBILITY OF DEFECT AFTER CLEANING. 5. CHECKED INJECTION MOLDING MACHINE FOR PLUNGER 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 2 HOUR. AFTER SHUTDOWN) D. CONDUCT PROCESS INSPECTION EVERY 2 HOURS IN INJECTION LINE ¿ IF THERE IS ANY SIGN OF ABNORMALITY, THE LINE WORKER CLEANS THE MOLD IMMEDIATELY. 6. CHECKED TO CHANGE ANGLE OF PINCH CLAMP EVEN IN WORST INJECTION CONDITION THE PINCH CLAMP WOULD WORK PROPERLY. 7. INSPECT CAVITY NO.2 CAREFULLY FOR 3 MONTHS UNTIL SBDM MAKE SURE THAT THERE IS NO QUALITY ISSUE. CONCLUSION: 2 SAMPLES WAS RETURNED TO SBDM. BASED ON THE INVESTIGATION RESULT, THE LIKELY CAUSE MAY BE OCCURRED DURING CLAMP INJECTION PROCESS. ACCORDING TO THE INVESTIGATION BY RECEIVED COMPLAINT SAMPLES, THE CAVITY NUMBER OF UNFORMED CLAMPS IS CAVITY NO.2. IT IS LIKELY THERE WOULD BE RAW MATERIAL POWDER STOCK PROBLEM ON THE CAVITY NO.2.. THE CLAMP IS INJECTED IN HIGH TEMPERATURE (200¿~240¿) AND INJECTION GAS WAS NOT EMITTED PROPERLY SO, THE GAS WAS ACCUMULATED IN THE END POINT OF CLAMP AND IT CAUSED THE COMPLAINT CASE. ANOTHER POSSIBILITY IS WHEN INJECTION PROCESS WAS STARTED THE CONDITION OF THE PROCESS WAS NOT PROPER TEMPORALLY, CAUSING THE UNFORMED CLAMP ISSUE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV SET TUR Y-TUBE CLAMP IS NOT WORKING. THIS OCCURRED ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PINCH CLAMP WAS NOT WORKING WELL, WHEN CUSTOMER USE IV SET TUR Y TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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. 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 TUR Y-TUBE CLAMP IS NOT WORKING. THIS OCCURRED ON 2 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PINCH CLAMP WAS NOT WORKING WELL, WHEN CUSTOMER USE IV SET TUR Y TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595406 IV SET TUR Y-TUBE IV SET FPA BECTON DICKINSON 6002201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other