BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL EURO 125 S/C

    MDR report key: 12072287 · Received June 25, 2021

    Report

    Report Number
    1213809-2021-00456
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A CUSTOMER¿S FOURIER TRANSFORM INFRARED SPECTROSCOPY REPORT WAS RECEIVED AND REVIEWED. THE REPORT SHOWED IMAGES OF A LOOSE 5ML SYRINGE FILLED WITH UNIDENTIFIED LIQUID. A BLURRY FOREIGN MATTER PARTICLE WAS OBSERVED IN THE FLUID PATH OF THE SYRINGE WITH LIQUID. THE REPORTED FOREIGN MATTER PARTICLE WAS IDENTIFIED IN THE REPORT TO BE POLYESTER AND A BLUE COLORANT. THE DEFECT COULD NOT BE CONFIRMED TO HAVE DEFINITIVELY ORIGINATED AT THE MANUFACTURING PLANT, THEREFORE CORRECTIVE ACTIONS ARE NOT REQUIRED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE SAMPLE IT IS POSSIBLE THE FOREIGN MATTER POLYESTER PARTICLE WAS INADVERTENTLY INTRODUCED DURING THE SYRINGE MANUFACTURING PROCESS. OUR ASSOCIATES WEAR SMOCKS MADE OF POLYESTER MATERIAL. HOWEVER, IT IS ALSO POSSIBLE THE PARTICLE WAS INTRODUCED BY ANOTHER POLYESTER SOURCE DURING A DOWNSTREAM PRODUCTION PROCESS AT THE CUSTOMER¿S LOCATION. UNFORTUNATELY, SINCE THE SAMPLE IN THE PHOTOS HAD BEEN MANIPULATED PRIOR TO THE TIME THE FOREIGN MATTER PARTICLE WAS REPORTEDLY FOUND, IT IS NOT POSSIBLE TO DEFINITIVELY DETERMINE AT WHICH POINT IN TIME THE PARTICLE WAS INTRODUCED INTO THE SYRINGE. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML LL (B)(6) 125 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INDEED, DURING THE CANDLING OF OUR LAST PRODUCTION BATCH (DISTRIBUTED IN SYRINGES), WE NOTICED THE PRESENCE OF A PARTICLE. THIS PARTICLE HAS BEEN IDENTIFIED IN IR AND IS COMPOSED OF : POLYESTER. BLUE PIGMENT OF HELIOGEN BLUE TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964459 SYRINGE 5ML LL EURO 125 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0183043 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1