BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7349726 · Received March 19, 2018

    Report

    Report Number
    3002682307-2018-00063
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 24, 2018
    Report Date
    March 28, 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
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION WE HAVE BEEN PROVIDED WITH 5 REFERENCE SAMPLES. THE ANALYZED SAMPLES DID NOT SHOW ANY DEFECT, SO WE COULD NOT CONFIRMED THE REPORTED ISSUE. BHR REVIEW: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2025 (OCTOBER 1 - 4TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239 Nº4238, Nº4219, Nº4214, AND Nº4201, IN LOT #7265379 (SEPTEMBER 25 - 30TH, 2017) AND IN LOT #7269123 (SEPTEMBER 30TH - OCTOBER 6TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7269048, #7265365, AND #7258037 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7269113, #7265368, #7258038, AND #7251466 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. INVESTIGATION CONCLUSION: ROOT CAUSE ANALYSIS WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD BE 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. CONFIRMATION: THE REFERENCE SAMPLES DID NOT PRESENT ANY DEFECT. NO ISSUE FOUND IN THE BHR. WE COULD NOT CONFIRM THE REPORTED ISSUE. CAPA DETERMINATION: NO BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (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 A DISCARDIT¿ II SYRINGE LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194389 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1710187

    Patients

    Seq Age Sex Outcome Treatment
    1 Other