BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA

    MDR report key: 8390764 · Received March 5, 2019

    Report

    Report Number
    1220246-2019-00940
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    February 12, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867239951
    PMA / PMN Number
    BK180180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS IN RESPONSE TO AN FDA LETTER FOR REPORT NUMBER 1220246-2019-00940 ASKING FOR MORE DETAILS ON DEVICE PART NUMBER VERSUS 510(K) NUMBER (K121124) AS RECEIVED IN THE ORIGINAL SUBMISSION. THE DEVICE PART NUMBER REMAINS THE SAME AS IN THE ORIGINAL SUBMISSION, ABS-10062T THIS DEVICE WAS MOST RECENTLY CLEARED FOR UNDER 510(K) BK180180. THIS WILL BE THE CORRECTED INFORMATION FOR THIS FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SHOULDER DMC PROCEDURE THE TUBE WAS CRACKED AND LEAKING BLOOD. THE BLOOD WAS MINIMAL AND DID NOT COME IN CONTACT WITH ANYONE'S SKIN. HOWEVER, A SMALL AMOUNT OF BLOOD ESCAPED OUTSIDE OF THE TUBE. THIS WAS DISCOVERED BEFORE IT SPILLED ONTO THE FLOOR. THE DEVICE WAS CLEANED AND THE KIT WAS REPLACED SO THE PROCEDURE COULD BE COMPLETED WITHOUT ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184280 ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING ORG ARTHREX, INC. ABS-10062T 831788025 00888867239951

    Patients

    Seq Age Sex Outcome Treatment
    1 Other