BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 8057090 · Received November 9, 2018

    Report

    Report Number
    3002682307-2018-00270
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    April 24, 2018
    Report Date
    November 7, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903091102
    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 · 1

    (B)(6). INVESTIGATION SUMMARY: 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 (FEBRUARY 20TH ¿ 21ST, 2018). SYRINGES WERE ASSEMBLED IN MACHINE Nº4253, Nº4235, Nº4213, Nº4212, AND Nº4203, IN LOT #8050711 (FEBRUARY 19TH - 26TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8050842, AND #8043958, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8050852 , AND #8043936, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. AFTER THE EVALUATION OF THE RECEIVED SAMPLE, BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD/WAS PRODUCED BECAUSE 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. INVESTIGATION CONCLUSION: BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLE. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THE PROVIDED SAMPLE. AFTER THAT BD COULD DETERMINE A DAMAGE IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. BD COULD CONFIRM THE REPORTED ISSUE. AFTER THE EVALUATION OF THE RECEIVED SAMPLE, BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD/WAS PRODUCED BECAUSE 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. ROOT CAUSE DESCRIPTION: DAMAGE IN THE PLUNGER LIP PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD DISCARDIT¿ II SYRINGES LEAKED FROM THE PLUNGER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897455 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802274 00382903091102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other