BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE SIGNAL BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 12037247 · Received June 21, 2021

    Report

    Report Number
    9617032-2021-00653
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-06-17. H6: INVESTIGATION SUMMARY: BD RECEIVED 6 SAMPLES, 2 FROM EACH LOT NUMBER REPORTED, AND 11 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODES FOR NO FLASH BACK, PAINFUL VENIPUNCTURE, LEAKAGE, AND INSUFFICIENT BLOOD FLOW WERE NOT OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION UNDER A MICROSCOPE AND NO CANNULA POINT DEFECTS WERE OBSERVED THAT COULD CAUSE A PAINFUL VENIPUNCTURE. ALL 6 SAMPLES WERE EACH USED TO DRAW 5 TUBES WITH WATER FROM AN ELEVATED RESERVOIR TO SIMULATE VENOUS PRESSURE. FLASH WAS VISIBLE IN THE FLASH CHAMBERS, AND ALL TUBES FILLED AS EXPECTED. NO DEFECTS WERE OBSERVED IN THE RETURNED SAMPLES 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. 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER THERE WAS POOR SLEEVE FUNCTION. THE INSUFFICIENT BLOOD FLOW EVENT OCCURRED 10 TIMES. THE PAINFUL NEEDLE INSERTION EVENT OCCURRED 4 TIMES. THE LEAKAGE EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS NO FLASH BACK WHEN USED ON GOOD VEINS, PAIN/BRUISING ON INSERTION, AND BLOOD FLOW WAS REALLY SLOW. ON ONE OCCASION, THE NEEDLE WAS INSERTED AND BLOOD STARTED TO FOLLOW THROUGH THE INSIDE OF THE PRE ATTACHED HOLDER, THE PHLEBOTOMIST SAID THAT HER GLOVES WERE COVERED WITH BLOOD.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0238400. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2020-08-25. MEDICAL DEVICE LOT #: 0133833. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2020-05-12. MEDICAL DEVICE LOT #: 1026701. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2021-01-26.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER THERE WAS POOR SLEEVE FUNCTION. THE INSUFFICIENT BLOOD FLOW EVENT OCCURRED 10 TIMES. THE PAINFUL NEEDLE INSERTION EVENT OCCURRED 4 TIMES. THE LEAKAGE EVENT OCCURRED 1 TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS NO FLASH BACK WHEN USED ON GOOD VEINS, PAIN/BRUISING ON INSERTION, AND BLOOD FLOW WAS REALLY SLOW. ON ONE OCCASION, THE NEEDLE WAS INSERTED AND BLOOD STARTED TO FOLLOW THROUGH THE INSIDE OF THE PRE ATTACHED HOLDER, THE PHLEBOTOMIST SAID THAT HER GLOVES WERE COVERED WITH BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929894 BD VACUTAINER ECLIPSE SIGNAL BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1