BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19121180 · Received April 16, 2024

    Report

    Report Number
    9617032-2024-00595
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 25, 2024
    Report Date
    March 29, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1: INITIAL REPORTER PHONE # (B)(6). E,1: INITIAL REPORTER FACILITY NAME: CHANGCHUN INFECTIOUS DISEASE HOSPITAL (CHANGCHUN TUBERCULOSIS HOSPITAL, CHANGCHUN CHEST HOSPITAL, CHANGCHUN FOURTH HOSPITAL, CHANGCHUN TUBERCULOSIS PREVENTION AND TREATMENT INSTITUTE). H.6 INVESTIGATION SUMMARY: MATERIAL #: 368835, LOT/BATCH #:3242438. BD RECEIVED ONE (1) SAMPLE AND THREE (3) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR BLOOD LEAKAGE WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH NINE (9) RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING TO DRAW 6 TUBES EACH 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER THAT BLOOD LEAKAGE WAS FOUND IN THE BLOOD COLLECTION NEEDLE HOLDER. THIS OCCURRED IN 5 PIECES. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893533 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3242438 30382903688358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown