BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 18219125 · Received November 28, 2023

    Report

    Report Number
    1024879-2023-00850
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 7, 2023
    Report Date
    February 6, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 368607. LOT/BATCH #: 3012295. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 10 VACUTAINER TUBES, AND THE ISSUE OF SLEEVE LEAKAGE WAS NOT 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 SLEEVE LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAS BEEN FOUND EXPERIENCING POOR SLEEVE FUNCTION. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THERE WAS A SLEEVE RUPTURE (THE RUBBER THAT COVERS THE DISTAL NEEDLE), CAUSING THE BLOOD TO LEAK INSIDE THE HOLDER. THE PHYSICAL SAMPLE IS NOT AVAILABLE FOR ANALYSIS. AS IMMEDIATE ACTION, THE SAMPLE ACQUISITION WAS COMPLETED THIS SAME WAY. SINCE THE ISSUE HAPPENED AT THE END OF PROCEDURE THERE WAS NO NECESSITY OF ANOTHER PUNCTURE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HAS BEEN FOUND EXPERIENCING POOR SLEEVE FUNCTION. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THERE WAS A SLEEVE RUPTURE (THE RUBBER THAT COVERS THE DISTAL NEEDLE), CAUSING THE BLOOD TO LEAK INSIDE THE HOLDER. THE PHYSICAL SAMPLE IS NOT AVAILABLE FOR ANALYSIS. AS IMMEDIATE ACTION, THE SAMPLE ACQUISITION WAS COMPLETED THIS SAME WAY. SINCE THE ISSUE HAPPENED AT THE END OF PROCEDURE THERE WAS NO NECESSITY OF ANOTHER PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602348 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 3012295 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown