BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 15983000 · Received December 14, 2022

    Report

    Report Number
    1024879-2022-00713
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 17, 2022
    Report Date
    January 4, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL? YES. D.10 RETURNED TO MANUFACTURER ON: 06-DEC-2022. BD RECEIVED 6 SAMPLES, THREE FROM LOT 2090159 AND THREE FROM LOT 2139829, FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY FUNCTIONAL SLEEVE TESTING, EACH USED TO DRAW 10 TUBES PER NEEDLE, AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE SLEEVE LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2090159. MEDICAL DEVICE EXPIRATION DATE: 2027-03-31. DEVICE MANUFACTURE DATE: 2022-03-31. MEDICAL DEVICE LOT #: 2139829. MEDICAL DEVICE EXPIRATION DATE: 2027-05-31. DEVICE MANUFACTURE DATE: 2022-05-19. 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 · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS POOR SLEEVE FUNCTION AND VISIBLE BLOOD IN FLASH CHAMBER (BLOOD POOLING OR LEAKAGE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE NEEDLE SHEATH DOES NOT RETRACT WHEN CHANGING TUBES AND THIS ALLOWS BLOOD TO POOL IN THE HUB WHEN USING PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS POOR SLEEVE FUNCTION AND VISIBLE BLOOD IN FLASH CHAMBER (BLOOD POOLING OR LEAKAGE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE NEEDLE SHEATH DOES NOT RETRACT WHEN CHANGING TUBES AND THIS ALLOWS BLOOD TO POOL IN THE HUB WHEN USING PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052837 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 SEE H.10 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown