BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX ANGEL PRP KIT (US TRAY)

    MDR report key: 19152768 · Received April 22, 2024

    Report

    Report Number
    1220246-2024-02201
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 26, 2024
    Report Date
    June 9, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867279919
    PMA / PMN Number
    BK180180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS A POSSIBLE CLOT IN THE DISPOSABLE KIT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN ABS-10061T ARTHREX ANGEL PRP KIT DID NOT PRODUCE ANY PRP, ONLY RBC AND PPP. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241725 ARTHREX ANGEL PRP KIT (US TRAY) PLATELET AND PLASMA SEPARATOR ORG ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY) 3345137043 00888867279919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown