BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 60ML LL BRAZIL

    MDR report key: 8869579 · Received August 7, 2019

    Report

    Report Number
    1911916-2019-00773
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    April 18, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE (1) SAMPLE AND ONE (1) PHOTO WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE SAMPLE WAS VISUALLY EXAMINED AND IT WAS OBSERVED THAT THERE WAS BLACK FOREIGN MATTER (FM) EMBEDDED IN THE SYRINGE BARREL TIP, THE SYRINGE BODY, AND THE SYRINGE FLANGE. ONE (1) PHOTO WAS ALSO PROVIDED BY THE CUSTOMER. THE PHOTO SHOWS THE TIP OF THE SYRINGE BARREL. THERE IS BLACK FM EMBEDDED IN THE BARREL TIP. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. EMBEDDED FM CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. NO CORRECTIVE OR PREVENTATIVE ACTION WILL BE TAKEN IN THE SCOPE OF THIS COMPLAINT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ON DEVICE WITH A BD SYRINGE 60ML LL BRAZIL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: WHEN OPENING THE SYRINGE 60ML IN ORDER TO USE, THE TIP WAS WITH A BLACK FOREIGN MATTER THAT SEEMS SYRINGE INK.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 PRIOR TO USE FOREIGN MATTER WAS DISCOVERED ON DEVICE WITH A BD SYRINGE 60ML LL (B)(6). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN OPENING THE SYRINGE 60ML IN ORDER TO USE, THE TIP WAS WITH A BLACK FOREIGN MATTER THAT SEEMS SYRINGE INK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662152 BD SYRINGE 60ML LL BRAZIL SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8240869

    Patients

    Seq Age Sex Outcome Treatment
    1 Other