BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE

    MDR report key: 14960774 · Received July 8, 2022

    Report

    Report Number
    9617032-2022-00629
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 22, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "MATERIAL #: 368837. LOT/BATCH #: 2062121. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WAS OBSERVED. ADDITIONALLY, 5 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 5 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. 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." DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE LEAKAGE OCCURS AND THE THREAD OF THE NEEDLE IS MORE THAN THE VACUTAINER HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "A NUMBER OF PRICKER'S ARE HAVING PROBLEMS WITH THE NEEDLE (368837) AND THE VACUTAINER HOLDER(368872). LEAKAGE OCCURS AND THE THREAD OF THE NEEDLE IS MORE THAN THE VACUTAINER HOLDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985454 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE BLOOD SPECIMEN COLLECTION DEVICE FMI BECTON, DICKINSON AND COMPANY (BD) 2062121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown