BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 15567688 · Received October 7, 2022

    Report

    Report Number
    8041187-2022-00582
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    August 15, 2022
    Report Date
    October 17, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    00382903001446
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 30-SEP-2022. H6: INVESTIGATION SUMMARY: THREE PHOTOS AND TWO SAMPLES WITHOUT PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE RETURNED PHOTOS, POOR STOPPER ASSEMBLY AND FOREIGN MATTER ON THE BARREL SURFACE WAS OBSERVED. AFTER EVALUATION OF THE SAMPLES, ONE SAMPLE WAS OBSERVED WITH POOR STOPPER ASSEMBLY AND ONE SAMPLE WAS OBSERVED WITH BROWN EMBEDDED FOREIGN MATTER IN THE BARREL WALL. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. FOR THE POOR STOPPER ASSEMBLY NONCONFORMANCE, THE PROBABLE ROOT CAUSE COULD BE THAT THE STOPPER WAS NOT PROPERLY SEATED ON THE LOWER TOOLING RESULTING IN THE NONCONFORMANCE. THERE IS A VISION SYSTEM AT THE ASSEMBLY MACHINE WHICH CAN DETECT AND AUTO-REJECT SUCH NONCONFORMANCES. THE RETURNED SAMPLE WAS CHALLENGED AT THE ASSEMBLY VISION SYSTEM AND WAS ABLE TO BE REJECTED AT THE 180-DEGREE POINT OF VIEW. THEREFORE, THE NONCONFORMANCE COULD HAVE BEEN ESCAPEES WHICH FLOWED TO THE NEXT PROCESS. THE TEAM HAS CONDUCTED A FEASIBILITY STUDY TO COVER 360-DEGREE POINT OF VIEW TO DETECT THE NONCONFORMANCE. THE REPORTED BATCH WAS MANUFACTURED BEFORE THE ACTION WAS TAKEN. FOR THE FOREIGN MATTER NONCONFORMANCE, THE PROBABLE ROOT CAUSE OF THE EMBEDDED FOREIGN MATTER COULD BE A RESULT OF DEGRADED POLYPROPYLENE. THIS MAY OCCUR DURING MOLD START UP AFTER A PROLONGED STOPPAGE OF THE INJECTION MOLDING MACHINE, WHICH MAY HAVE CAUSED OVERHEATED POLYMER ADDITIVE TO BE EMBEDDED IN TH SYRINGE. THE FLUSHING OF THE PARTS WAS NOT SUFFICIENT AND RESULTED IN PARTS TO FLOW TO THE NEXT PROCESS. AN ENHANCED CLEANING TO THE INJECTION SCREW OF THE 50ML SYRINGE MOLDING PRESS AND INSPECTION ON SEVEN SHOTS TO VERIFY THAT THERE IS NO OVERHEATED POLYMER ADDITIVE TO BE EMBEDDED IN THE SYRINGE HAS BEEN PERFORMED. THE REPORTED BATCH WAS MANUFACTURED BEFORE THE ACTION WAS TAKEN.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGES' STOPPERS WERE FOUND MISALIGNED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, THE PRODUCTION STAFF FOUND THAT A 50ML SYRINGE RUBBER STOPPER WAS ABNORMALLY UNEVEN BEFORE PRODUCTION AND USE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGES' STOPPERS WERE FOUND MISALIGNED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, THE PRODUCTION STAFF FOUND THAT A 50ML SYRINGE RUBBER STOPPER WAS ABNORMALLY UNEVEN BEFORE PRODUCTION AND USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236408 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 0052883 00382903001446

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown