BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7275335 · Received February 15, 2018

    Report

    Report Number
    3002682307-2018-00027
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 24, 2018
    Report Date
    March 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLES. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THIS PROVIDED PICTURE. WE HAVE ALSO BEEN PROVIDED WITH 400 REFERENCE SAMPLES. WE HAVE CARRIED OUT A LEAKAGE TEST FOR THE RETURNED REFERENCE SAMPLES, TO CHECK THE POSSIBLE PLUNGER OR BARREL DEFECT, AND IT HAS PROVED TO BE CORRECT TOO. WE CONFIRM THE REPORTED ISSUE FROM THE RETURNED PICTURE. 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 (B)(4) (SEPTEMBER 17 - 19TH, 2017). SYRINGES WERE ASSEMBLED IN (B)(4), IN LOT #7251002 (SEPTEMBER 11 - 18TH, 2017) AND IN LOT #7258082 (SEPTEMBER 18 - 25TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7258040, #7251464, #7244048, AND #7237223 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7258041, #7251467, AND #7244049 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. 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 PROVIDED PICTURE OF THE SAMPLE PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    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 THE BD DISCARDIT¿ II SYRINGE LEAKED BETWEEN THE PLUNGER AND SYRINGE. FOUND DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117317 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1709187

    Patients

    Seq Age Sex Outcome Treatment
    1 Other