BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 14271757 · Received May 3, 2022

    Report

    Report Number
    1024879-2022-00255
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 21, 2022
    Report Date
    August 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: "MATERIAL #: 368609. LOT/BATCH #: 1223487. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR ILLEGIBLE EXPIRATION DATE PRINTING WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE ILLEGIBLE EXPIRATION DATE PRINTING. BD DETERMINED THAT THE ROOT CAUSE OF THE ILLEGIBLE LASER PRINTING WAS ATTRIBUTED TO SCRATCHES ON THE LASER LENS. A FULL LASER SERVICE WAS CONDUCTED ON THE LASER PRINTERS; LASER LENSES WERE CLEANED. THIS FULL SERVICE HAS BEEN IMPLEMENTED TO BE REPEATED ANNUALLY, TO MAINTAIN GOOD PERFORMANCE OF THE LASER PRINTERS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "OUR KIT PRODUCTION HAD EXPIRATION DATES AND LOT NUMBERS THAT ARE NOT PRINTED WELL. DUE TO NEARLY INVISIBLE PRINTED LOT NUMBERS AND EXPIRATION DATE, ITS QUITE IMPOSSIBLE TO PERFORM CHECKS (QA) ON THIS ITEM."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "OUR KIT PRODUCTION HAD EXPIRATION DATES AND LOT NUMBERS THAT ARE NOT PRINTED WELL. DUE TO NEARLY INVISIBLE PRINTED LOT NUMBERS AND EXPIRATION DATE, ITS QUITE IMPOSSIBLE TO PERFORM CHECKS (QA) ON THIS ITEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000913 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 1223487

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown