BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE SIGNAL BLOOD COLLECTION NEEDLE W/ INTEGRATED HOLDER

    MDR report key: 11942778 · Received June 4, 2021

    Report

    Report Number
    9617032-2021-00597
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    March 24, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY FROM EACH LOT NUMBER PROVIDED WERE EACH USED TO DRAW 5 BD VACUTAINER TUBES WITH WATER. THE WATER WAS DRAWN FROM AN ELEVATED RESERVOIR TO SIMULATE VENOUS PRESSURE. NO ISSUES WERE OBSERVED RELATING TO LEAKAGE AND ALL THE NON-PATIENT SLEEVES REMAINED INTACT AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER THERE WAS BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "BLOOD SPILL DURING BLOOD SAMPLING. LEAK AT LAST PIPE."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0329555. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2020-11-24. MEDICAL DEVICE LOT #: 0133833. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2020-05-12. 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 WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER THERE WAS BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS "BLOOD SPILL DURING BLOOD SAMPLING. LEAK AT LAST PIPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837961 BD VACUTAINER ECLIPSE SIGNAL BLOOD COLLECTION NEEDLE W/ INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1