BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML

    MDR report key: 8362585 · Received February 22, 2019

    Report

    Report Number
    3002682307-2019-00160
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    February 4, 2019
    Report Date
    April 1, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR:1806191. 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 Nº2022 (JUNE 14TH - 15TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4251, Nº4208, AND Nº4204, IN LOT #8162871 (JUNE 11TH ¿ 18TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8163667, #8156556, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8163671, #8156560 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS BEEN PROVIDED WITH PHOTOS AND AFFECTED SAMPLES. AFTER THE EVALUATION OF THE RETURNED SAMPLES, WE CONFIRMED THE REPORTED ISSUE, AND CONCLUDED THAT THE WHITE PARTICLES INSIDE THE SYRINGE WERE COMPOSED BY LUBRICANT FROM THE SYRINGE BARREL. CONCLUSION(S): PARTICLES COMPOSED BY LUBRICANT, WHICH IS INCLUDED IN THE PLASTIC FORMULATION AND IT IS INHERENT TO THE DESIGN AND FUNCTION OF 2-PIECE SYRINGES. WE HAVE INITIATED THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTIONS FOR THIS ISSUE. CAPA #207816.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 20ML EXPERIENCED FOREIGN MATTER CONTAMINATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 20ML EXPERIENCED FOREIGN MATTER CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157595 SYRINGE S2 20ML SYRINGE FMF BECTON DICKINSON, S.A. 1806191

    Patients

    Seq Age Sex Outcome Treatment
    1 Other