BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD SYRINGE

    MDR report key: 11868026 · Received May 22, 2021

    Report

    Report Number
    3002682307-2021-00205
    Event Type
    Malfunction
    Date Received
    May 22, 2021
    Date of Event
    April 18, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/25/2021. . H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2010166 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, PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLES, FOREIGN MATTER WAS OBSERVED ON THE BARREL SURFACE. THE FOREIGN MATTER WAS IDENTIFIED AS A GREASE SPOT. IT HAS BEEN DETERMINED THAT THIS INCIDENT RESULTED DUE TO A SMALL QUANTITY OF GREASE/LUBRICANT FROM ONE OF THE MACHINE STATIONS FALLING ONTO THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD EMERALD¿ SYRINGES HAD BROWN FOREIGN MATTER IN THEIR PACKAGING UNITS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 BD EMERALD SYRINGES HEAVILY CONTAMINATED WITHIN THE STERILE PACKAGING WITH BROWN CONTAMINANT".

    Additional Manufacturer Narrative · 1

    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 2 BD EMERALD¿ SYRINGES HAD BROWN FOREIGN MATTER IN THEIR PACKAGING UNITS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 BD EMERALD SYRINGES HEAVILY CONTAMINATED WITHIN THE STERILE PACKAGING WITH BROWN CONTAMINANT"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764757 BD EMERALD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2010166

    Patients

    Seq Age Sex Outcome Treatment
    1