BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML 22GA 1-1/2IN BD CHINA

    MDR report key: 9975431 · Received April 17, 2020

    Report

    Report Number
    3002682307-2020-00135
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    April 2, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901101 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS NEITHER A PHYSICAL SAMPLE NOR A PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE PROVIDED CUSTOMER FEEDBACK, OUR QUALITY TEAM HAS CONCLUDED THAT IT IS POSSIBLE THE REPORTED INCIDENT RESULTED FROM AN ERROR IN THE ASSEMBLY PROCESS. IF THE CANNULA COMPONENT IS INCORRECTLY POSITIONED WITHIN THE HUB COMPONENT, THE ADHESIVE CAN BLOCK THE CANNULA. THE SYRINGE CONNECTIVITY ISSUE COULD HAVE RESULTED FROM EXCESSIVE PRESSURE CAUSED BY THE CLOGGED CANNULA. WITHIN THE MANUFACTURING FACILITY, THE MACHINE OPERATORS PERFORMED VISUAL INSPECTIONS EVERY THIRTY MINUTES FOR CLOG CONDITIONS. DUE TO THE CURRENT PREVENTIVE MEASURES IN PLACE, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. INVESTIGATION CONCLUSION: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2020 (JANUARY 9TH ¿ 10TH, 2019). NEEDLES WERE ASSEMBLED IN MACHINE Nº4413, Nº4408, IN LOT #8325716 (NOVEMBER 25TH ¿ DECEMBER 2ND, 2018) AND IN LOT #8344804 (DECEMBER 17TH ¿ 20TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE CANNULA LOTS #8208701, #8178739, #8011736, #8208701, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE EPOXY LOTS #I682565301, #I6828440924, #I682633636, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. NO PICTURE OR SAMPLE AVAILABLE FOR EVALUATION. BASED ON THE CUSTOMER FEEDBACK, WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED DUE TO SOME PROBLEM IN THE ASSEMBLY PROCESS (FOR EXAMPLE, NOT ENOUGH VACUUM), THE CANNULA WAS NOT PLACED IN THE CORRECT POSITION INTO THE HUB AND, AS A CONSEQUENCE, THE EPOXY USED TO JOIN BOTH PIECES BLOCKED THE CANNULA. THE CONNECTIVITY ISSUE COULD BE RELATED WITH AN EXCESSIVE PRESSURE IN THE DEVICE CONNECTION DURING USE, ORIGINATED DUE TO THE CLOGGED CANNULA. EVERY 30 MINUTES, CLOG CONDITION IS VISUALLY INSPECTED BY MACHINE OPERATOR. IN ADDITION, AS IN-COMING INSPECTION EACH CANNULA BATCH IS ALSO INSPECTED BY QUALITY OPERATOR. ALL THE PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NO CHANGES IN THE PROCESS HAVE BEEN IMPLEMENTED WHICH COULD GENERATE THE DEFECT BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CERTAIN THAT THE PROBABILITY OF OCCURRENCE OF THIS NON-CONFORMANCE IS VERY LOW AND ALWAYS, IN SPORADIC AND EXCEPTIONAL CASES. ROOT CAUSE DESCRIPTION: NOT ABLE TO CONFIRM THE EXACT ROOT CAUSE. POSSIBLE PROBLEM IN THE NEEDLE ASSEMBLY PROCESS. RATIONALE: WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION, NO ACTIONS ARE REQUIRED. IN ADDITION, A REVIEW OF THE P-EURA (B)(4) INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE FMEA DOCUMENTATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 SYRINGES S2 5ML 22GA 1-1/2IN BD CHINA WERE FOUND BLOCKED AND LOOSE BEFORE USE, RESULTING IN MEDICATION WASTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN THE NURSE OPERATED, THE NEEDLE WAS BLOCKED AND LOOSEN. IT RESULTED IN MEDICINE WASTE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435635 SYRINGE S2 5ML 22GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1901101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other