BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 11838265 · Received May 17, 2021

    Report

    Report Number
    3002682307-2021-00194
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2010206 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER WERE OBTAINED FROM THE MANUFACTURING FACILITY FOR EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO SIGNS OF DEFECT WERE OBSERVED. ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EMERALD¿ SYRINGE LEAKED FROM THE SPINAL NEEDLE ATTACHMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE QUALITY OF EMERALD 2 ML SYRINGE HAS DECLINED. WHEN INJECTING FLUID WITH A SPINAL NEEDLE TO THE PATIENT, THE SYRINGE LEAKS FROM SYRINGE-NEEDLE ATTACHMENT POINT."

    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 BD EMERALD¿ SYRINGE LEAKED FROM THE SPINAL NEEDLE ATTACHMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE QUALITY OF EMERALD 2 ML SYRINGE HAS DECLINED. WHEN INJECTING FLUID WITH A SPINAL NEEDLE TO THE PATIENT, THE SYRINGE LEAKS FROM SYRINGE-NEEDLE ATTACHMENT POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734987 BD EMERALD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010206

    Patients

    Seq Age Sex Outcome Treatment
    1