BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML

    MDR report key: 8392140 · Received March 5, 2019

    Report

    Report Number
    3002682307-2019-00174
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    February 15, 2019
    Report Date
    April 22, 2019
    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
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: 1808110: BD HAS 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 Nº2024 (AUGUST 1ST ¿ 22ND, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236, Nº4220, AND Nº4210, IN LOT #8211651 (JULY 30TH ¿ AUGUST 2ND, 2018) AND IN LOT #8233523 (AUGUST 22ND ¿ 27TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8212963, #8205829, #8233870, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8212966, #8205833, #8198682, #8233874 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS BEEN PROVIDED WITH A PICTURE AND THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE, BD CONFIRMED THE REPORTED ISSUE, AND IDENTIFIED THE FOREIGN MATTER AS PRINTING FOIL PARTICLES IN THE FLUID PATH. WE COULD CONFIRM THE REPORTED ISSUE. CONCLUSION(S): AFTER ANALYZING THE PICTURE AND THE AFFECTED SAMPLE PROVIDED TO THE MANUFACTURING SITE FOR EVALUATION, WE COULD SEE THE REPORTED FOREIGN MATTER AND CONFIRM THE REPORTED ISSUE. THE PROCESS USED TO PRINT THE SCALE IN BD DISCARDIT SYRINGES IS CALLED "HOT STAMPING" PROCESS, IN WHICH, THROUGH A HEATED METAL STAMP, THE SCALE IS TRANSFERRED FROM THE PRINTING FOIL TO THE BARREL. IN SOME CASES, THIS PRINTING FOIL DUE TO A CLOG IN THE PRINTING STATION, MUST BE MONITORED BY THE OPERATOR. WHEN THIS SITUATION HAPPENS, THE MACHINE STOPS AUTOMATICALLY, AND THE OPERATOR SHOULD CUT THE PRINTING FOIL REEL TO SOLVE THE CLOG. DURING THIS CUTTING PROCESS OF THE PRINTING FOIL, SOME PARTICLES COULD REMAIN IN THE MACHINE, AND IN THIS CASE, THESE FOIL PARTICLES FINALLY ENDED IN ONE SYRINGE BARREL, PRODUCING THE REPORTED ISSUE. THEREFORE, THE REPORTED NONCONFORMANCE IS CAUSED BY A DEFECTIVE FOIL REEL AND HUMAN ERROR. WE CONCLUDED THAT IT HAS BEEN AN ISOLATED CASE WITH A NEGLIGIBLE FREQUENCY OF OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 5ML EXPERIENCED FOREIGN MATTER CONTAMINATION WITH THE CUSTOMER STATING, ¿A PARTICLE WAS DETECTED WHEN THE SOLUTION WAS DRAWN UP, WHICH MUST HAVE COME FROM THE SYRINGE¿.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT THE SYRINGE S2 5ML EXPERIENCED FOREIGN MATTER CONTAMINATION WITH THE CUSTOMER STATING, ¿A PARTICLE WAS DETECTED WHEN THE SOLUTION WAS DRAWN UP, WHICH MUST HAVE COME FROM THE SYRINGE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186401 SYRINGE S2 5ML SYRINGE FMF BECTON DICKINSON, S.A. 1808110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other