BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 8139565 · Received December 6, 2018

    Report

    Report Number
    3002682307-2018-00303
    Event Type
    Malfunction
    Date Received
    December 6, 2018
    Date of Event
    November 19, 2018
    Report Date
    December 27, 2018
    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: 1805232: 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 Nº2028 (MAY 19TH - 20TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE Nº4253, Nº4235, Nº4213, Nº4212, AND Nº4203, IN LOT #8134776. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8135532, AND #8128590, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8135536, #8128594, AND #8119956, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 1805232: 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 Nº2023 (JUNE 9TH - 12TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE Nº4253, Nº4235, Nº4213, Nº4212, AND Nº4203, IN LOT #8162870, AND #8155591. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8163666, AND #8156555, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8163670, #8156559, AND #8142766, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE BEEN PROVIDED WITH TWO REFERENCE SAMPLES. WE HAVE BEEN PROVIDED ALSO WITH THE AFFECTED SAMPLES. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THE PROVIDED AFFECTED SAMPLE. AFTER THAT WE COULD DETERMINE DAMAGE TO THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. WE COULD CONFIRM THE REPORTED ISSUE. NO ISSUE FOUND IN THE REFERENCE SAMPLES. CONCLUSION(S): AFTER THE EVALUATION OF THE RECEIVED SAMPLES, WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD WAS PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGE WAS LEAKED.

    Additional Manufacturer Narrative · 1

    (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 WAS LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980115 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1806169

    Patients

    Seq Age Sex Outcome Treatment
    1 Other