BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT II SYRINGE W/O NEEDLE

    MDR report key: 8419605 · Received March 14, 2019

    Report

    Report Number
    3002682307-2019-00184
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 19, 2019
    Report Date
    March 27, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURE DATE: 2018-09-06.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR: 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 (SEPTEMBER 10TH - 11TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4251, Nº4208, AND Nº4204, IN LOT #8246949 AND LOT #8253793. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BD HAS ALSO REVIEWED THE BARREL LOTS #8254830, #8247761, #8240565, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS ALSO REVIEWED THE PLUNGER LOTS #8254837, #8247765, #8240569 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE, BD 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 BEFORE USE OF THE DISCARDIT¿ II SYRINGE W/O NEEDLE THERE WAS PLASTIC PARTICLE INSIDE THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE DISCARDIT¿ II SYRINGE W/O NEEDLE THERE WAS PLASTIC PARTICLE INSIDE THE SYRINGE.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE DISCARDIT¿ II SYRINGE W/O NEEDLE THERE WAS PLASTIC PARTICLE INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216255 DISCARDIT II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1809194

    Patients

    Seq Age Sex Outcome Treatment
    1 Other