BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMITHS MEDICAL SAF-T HOLDER DEVICE WITH MULTI-SAMPLE MALE LUER ADAPTER

    MDR report key: 11348350 · Received February 18, 2021

    Report

    Report Number
    MW5099491
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 16, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN OBTAINING MORNING LABS FROM PICC LINE USING SMITHS MEDICAL SAF-T HOLDER DEVICE WITH MULTI-SAMPLE MALE LUER ADAPTER. AFTER ATTACHING DEVICE AND OBTAINING SAMPLES, RN TWISTED OFF DEVICE TO FLUSH AND MALE LUER ADAPTER DISCONNECTED FROM HOLDER DEVICE AND GOT STUCK IN PICC LINE LUMEN CAP. UNABLE TO GET BROKEN PIECE OUT OF CAP SO RN CHANGED BLUE CAP ON PICC LINE. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238668 SMITHS MEDICAL SAF-T HOLDER DEVICE WITH MULTI-SAMPLE MALE LUER ADAPTER TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA SMITHS MEDICAL ASD, INC. 4077387

    Patients

    Seq Age Sex Outcome Treatment
    1