BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 9099216 · Received September 20, 2019

    Report

    Report Number
    1911916-2019-00990
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    August 30, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: FOUR SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE VISUALLY EXAMINED USING 10X MAGNIFICATION. DARK SPOTS WHICH WERE VISUALLY IDENTIFIED AS RUBMARKS WERE FOUND ON ALL FOUR RETURNED SAMPLES. ADDITIONALLY, THREE PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE PHOTO SHOWS FOUR SYRINGES AGAINST A WHITE BACKGROUND. ALL FOUR SYRINGES HAVE DARK SPOTS ON OR IN THE SYRINGE BARRELS. THE SECOND PHOTO SHOWS A CLOSER VIEW OF TWO OF THE SYRINGES FROM THE FIRST PHOTO. WHILE THIS PHOTO PROVIDES A BETTER VIEW OF THE FOREIGN MATTER (FM) IT CANNOT STILL DETERMINED WHAT THE FM IS OR IF IT IS EMBEDDED OR LOOSE. THE THIRD PHOTO SHOWS A CLOSER VIEW OF THE OTHER TWO SYRINGES FROM THE FIRST PHOTO. WHILE THIS PHOTO PROVIDES A BETTER VIEW OF THE FOREIGN MATTER (FM) IT CANNOT STILL DETERMINED WHAT THE FM IS OR IF IT IS EMBEDDED OR LOOSE. POSSIBLE ROOT CAUSE, A RUBMARK IS LIKELY CAUSED BY A BARREL OR PLUNGER ROD GETTING CAUGHT IN THE MACHINERY AND MAKING CONTACT WITH SYRINGES AS THEY ARE BEING PROCESSED. BD ACKNOWLEDGES THAT THE RETURNED SAMPLES HAVE RUBMARKS ON THEM WHICH WOULD NOT MEET THE QUALITY CRITERIA OF FOREIGN MATTER ¿ EMBEDDED ON COMPONENT. AS A MEANS OF RAISING AWARENESS TO THE ISSUE OBSERVED BY THE CUSTOMER A QUALITY ALERT WILL BE ISSUED TO THE ASSOCIATES INVOLVED IN THE PRODUCTION OF THIS MATERIAL. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED WITH A SYRINGE 30ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I HAVE JUST LEARNED THAT 20% OF THE SYRINGES OF ARTICLE 62.301229 BATCH 1802268 AND BATCH 8066655 HAVE CONTAMINATIONS. THERE IS INK ON THE SYRINGES AND WE CAN THEREFORE NOT APPROVE THESE SYRINGES. WE WOULD LIKE TO EXCHANGE THESE 2 BATCHES FOR OTHER BATCHES THAT DO NOT HAVE THIS COMPLAINT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 FOREIGN MATTER OCCURRED WITH A SYRINGE 30ML LL BNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "I HAVE JUST LEARNED THAT 20% OF THE SYRINGES OF ARTICLE 62.301229 BATCH 1802268 AND BATCH 8066655 HAVE CONTAMINATIONS. THERE IS INK ON THE SYRINGES AND WE CAN THEREFORE NOT APPROVE THESE SYRINGES. WE WOULD LIKE TO EXCHANGE THESE 2 BATCHES FOR OTHER BATCHES THAT DO NOT HAVE THIS COMPLAINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895266 SYRINGE 30ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON AND COMPANY 8066655

    Patients

    Seq Age Sex Outcome Treatment
    1 Other