BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD A-LINE¿

    MDR report key: 20796919 · Received November 27, 2024

    Report

    Report Number
    9617032-2024-01874
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 15, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643764
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER ADDRESS: (B)(6). INVESTIGATION SUMMARY: "MATERIAL#: 364376, LOT/BATCH#: 4003396. BD RECEIVED 1 SAMPLE AND 2 PHOTOS FOR INVESTIGATION. THE SAMPLE AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR LOOSE CAP WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND THE ISSUE OF LOOSE CAP 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 LOOSE CAP. 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 AFTER DRAWING A BLOOD SAMPLE WITH A BD A-LINE¿ SYRINGE THE CAP DETACHED FROM THE HUB DURING TRANSPORTATION. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434807 BD A-LINE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4003396 50382903643764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown