BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 19583563 · Received June 21, 2024

    Report

    Report Number
    9617032-2024-00953
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 22, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903688358
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "MATERIAL #: 368835 LOT/BATCH #: 4030223 BD HAD NOT RECEIVED SAMPLES, BUT FIVE (5) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WAS OBSERVED. ADDITIONALLY, 10 RETAINED SAMPLES WERE USED TO DRAW 6 TUBES EACH WITH WATER AND THE ISSUE OF 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 OF 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."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE USE OF BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER, BLOOD LEAKED FROM THE BACK SLEEVE INTO THE HOLDER. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115991 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4030223 30382903688358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown