BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX ANGEL PRP KIT (US TRAY)

    MDR report key: 17190111 · Received June 23, 2023

    Report

    Report Number
    1220246-2023-06968
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 2, 2023
    Report Date
    October 31, 2024
    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 HAS NOT YET BEEN DETERMINED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A MOST LIKELY CAUSE IF A ROOT CAUSE CAN NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS CONFIRMED PER PICTURE EVALUATION. THE ABS-10061T ARTHREX ANGEL PRP KIT TUBING WAS NOTICED THE BLOOD WAS LEAKING INSIDE AR-160060 ANGEL CENTRIFUGE. (B)(4) WAS OPENED FOR THIS ISSUE. THIS IS A KNOWN MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN ABS-10061T ARTHREX ANGEL PRP KIT TUBING WAS LOOSE, AND BLOOD LEAKED. ALSO, THE AR-160060 ANGEL CENTRIFUGE WIRING WAS LOOSE. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING A PRR INJECTION PROCEDURE ON (B)(6) 2023. THE PATIENT WAS NOT UNDER GENERAL ANESTHESIA. THE CASE WAS COMPLETED USING A NEW AR-160060 ANGEL CENTRIFUGE AND AN ABS-10010S ARTHREX ACP DOUBLE SYRINGE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865560 ARTHREX ANGEL PRP KIT (US TRAY) PLATELET AND PLASMA SEPARATOR ORG ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY) 2346127512 00888867279919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown