BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 10742746 · Received October 27, 2020

    Report

    Report Number
    3002682307-2020-00326
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 1, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 2020-10-02. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2003320 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE SAMPLES AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, FOREIGN MATTER WAS OBSERVED EMBEDDED WITHIN THE TIP OF THE SYRINGE. THE EMBEDDED PARTICLES RESULTED FROM THE INJECTION MOLDING MACHINE. DUE TO THE HIGH WORKING TEMPERATURES, DIFFERENT GASES ARE PRODUCED INSIDE OF THE MOLD. THE GASES SHOULD BE EXPELLED THROUGH CONDUITS, OUTSIDE OF THE MOLD CAVITY. IF THE GAS EXPULSION IS NOT DONE CORRECTLY, BURNT PARTICLES CAN RESULT WITHIN THE MOLD CAVITY. THIS IS A COSMETIC DEFECT ONLY AS THE PIECES ARE EMBEDDED WITHOUT THE POSSIBILITY OF DETACHMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD EMERALD¿ SYRINGE HAD A "BROWN MARK" ON IT THAT WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE SEEMS TO BE A BROWN MARK AT THE END OF ONE OF THEM."

    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 BD EMERALD¿ SYRINGE HAD A "BROWN MARK" ON IT THAT WAS NOTICED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE SEEMS TO BE A BROWN MARK AT THE END OF ONE OF THEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209471 BD EMERALD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2003320

    Patients

    Seq Age Sex Outcome Treatment
    1