BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 8181837 · Received December 19, 2018

    Report

    Report Number
    3002682307-2018-00321
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 3, 2018
    Report Date
    January 8, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903002962
    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- WE HAVE 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 (MAY 24TH - 25TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4251, Nº4208, AND Nº4204, IN LOT #8127719 (MAY 7TH ¿ 14TH, 2018) AND IN LOT #8141661 (MAY 21ST ¿ 28TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8128591, #8119953, #8142763, #8135533, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8128595, #8119957, #8142767, #8135537 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE AND PICTURE, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGE W/O NEEDLE HAD FOREIGN MATTER INSIDE THE BARREL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. (B)(6). 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 BD DISCARDIT¿ II SYRINGE W/O NEEDLE HAD FOREIGN MATTER INSIDE THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017283 BD DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1805273 00382903002962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other