BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ 10ML SYRINGE

    MDR report key: 6980450 · Received October 26, 2017

    Report

    Report Number
    3002682307-2017-00075
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    October 3, 2017
    Report Date
    October 6, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1706162, MEDICAL DEVICE EXPIRATION DATE: 05/31/2022, DEVICE MANUFACTURE DATE: 06/12/2017. MEDICAL DEVICE LOT #: 1706391, MEDICAL DEVICE EXPIRATION DATE: 05/31/2022, DEVICE MANUFACTURE DATE: 06/13/2017. PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND/OR NOT SOLD IN THE US. RESULTS: INVESTIGATION: NO SAMPLE WAS AVAILABLE FOR INSPECTION. A PHOTO OF THE AFFECTED SAMPLE WAS AVAILABLE FOR INVESTIGATION. AFTER THE EVALUATION OF THE PROVIDED PICTURE, SAMPLE SHOWED A BIG AMOUNT OF SILICONE STUCK AT THE STOPPER OF THE SYRINGE, WE COULD CONFIRM THE REPORTED ISSUE. DHR/BHR REVIEW: A DEVICE REVIEW WAS PERFORMED ON LOT#1706162. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. REVIEWED THE STOPPER LOTS#7160149, #7156075, #7145322, AND #7139251 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. LOT#1706391: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO VIEWED THE STOPPER LOTS#7251500, #7244063, #7237242, AND #7145322 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. CONCLUSION: THE RETURNED PICTURE OF THE AFFECTED SAMPLE PRESENTED AN EXCESS OF SILICONE OIL IN THE STOPPER. WE WERE ABLE TO CONFIRM THE REPORTED ISSUE. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN MATTER WAS FOUND IN THE "GREEN STOPPER" OF A BD EMERALD¿ 10 ML SYRINGE PRIOR TO USE. NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761946 BD EMERALD¿ 10ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other