BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 10ML LS EMERALD

    MDR report key: 8441990 · Received March 21, 2019

    Report

    Report Number
    3002682307-2019-00207
    Event Type
    Injury
    Date Received
    March 21, 2019
    Date of Event
    March 6, 2019
    Report Date
    May 9, 2019
    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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: AS NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1811270, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THIS ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 10ML LS EMERALD EXPERIENCED LEAKAGE. THE CUSTOMER REPORTED, "CUSTOMER REPORTED THAT HE HAD SEVERAL PROBLEMS WITH THE 10ML EMERALD BD SYRINGES ON SEVERAL OCCASIONS. THE PLUNGER DISCONNECTS FROM THE SYRINGE AND THE SAMPLED MEDICINE IS LOST. IT'S A VERY ANNOYING FLAW!"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 SYRINGE 10ML LS EMERALD EXPERIENCED LEAKAGE. THE CUSTOMER REPORTED, "CUSTOMER REPORTED THAT HE HAD SEVERAL PROBLEMS WITH THE 10ML EMERALD BD SYRINGES ON SEVERAL OCCASIONS. THE PLUNGER DISCONNECTS FROM THE SYRINGE AND THE SAMPLED MEDICINE IS LOST. IT'S A VERY ANNOYING FLAW!"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235411 SYRINGE 10ML LS EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1811270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other