BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 9284655 · Received November 6, 2019

    Report

    Report Number
    3002682307-2019-00592
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 22, 2019
    Report Date
    January 16, 2020
    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
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TEN PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLES, WHITE PARTICLES WERE OBSERVED WITHIN THE SYRINGE. IT WAS CONCLUDED THAT THE PARTICLES WERE COMPOSED OF THE LUBRICANT FROM THE SYRINGE BARREL. THE LUBRICANT IS INCLUDED IN THE PLASTIC FORMULATION AND IS INHERENT TO THE DESIGN AND FUNCTION OF THE TWO PIECE SYRINGES. A DEVICE HISTORY RECORD REVIEW FOR LOT NUMBER 9170677 WAS PERFORMED AND THE REVIEW DID NOT REVEAL ANY SIGNS OF NON-CONFORMANCE DURING THE PRODUCTION PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "WHITE PARTICLES / LUBRICANT" IN "BIG QUANTITIES" WERE FOUND IN THE BD DISCARDIT¿ II SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT POSSIBLE TO USE IN OUR PRODUCTION DUE TO A WHITE PARTICLES / LUBRICANT/ IN SYRINGES. THESE PARTICLES ARE IN A BIG QUANTITIES AND ALSO DIFFERENT POSITIONS AND OUR CUSTOMERS REFUSE TO USE THESE SYRINGES."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 "WHITE PARTICLES / LUBRICANT" IN "BIG QUANTITIES" WERE FOUND IN THE BD DISCARDIT¿ II SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT POSSIBLE TO USE IN OUR PRODUCTION DUE TO A WHITE PARTICLES / LUBRICANT/ IN SYRINGES. THESE PARTICLES ARE IN A BIG QUANTITIES AND ALSO DIFFERENT POSITIONS AND OUR CUSTOMERS REFUSE TO USE THESE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077701 BD DISCARDIT II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 9170677

    Patients

    Seq Age Sex Outcome Treatment
    1 Other