BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LS EMERALD

    MDR report key: 11297815 · Received February 8, 2021

    Report

    Report Number
    3002682307-2021-00040
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 14, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2002138. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE ORIGINALLY 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. THE RETAINED SAMPLES WERE EVALUATED AND NO SIGNS OF DEFECT WERE IDENTIFIED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGES 10ML LS EMERALD EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA/NEEDLE/SYRINGE OR ANY OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT WHERE LOOSE PARTICLES WERE OBSERVED MOST LIKELY COMING OFF THE PACKAGING.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1911161, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-11-11. MEDICAL DEVICE LOT #: 2002138, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-01-29. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGES 10ML LS EMERALD EXPERIENCED FOREIGN MATTER IN THE DEVICE CANNULA/NEEDLE/SYRINGE OR ANY OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED A COMPLAINT WHERE LOOSE PARTICLES WERE OBSERVED MOST LIKELY COMING OFF THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188346 SYRINGE 10ML LS EMERALD SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1