BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LS EMERALD

    MDR report key: 10991559 · Received December 11, 2020

    Report

    Report Number
    3002682307-2020-00398
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 13, 2020
    Report Date
    March 17, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2003122. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS WERE OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 10ML LS EMERALD EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF SYRINGE USED FOR ADMINISTERING ANAESTHESIA DURING SAMPLING OF THE PROSTATE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 10ML LS EMERALD EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF SYRINGE USED FOR ADMINISTERING ANAESTHESIA DURING SAMPLING OF THE PROSTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457934 SYRINGE 10ML LS EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 2003122

    Patients

    Seq Age Sex Outcome Treatment
    1