BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX ANGEL PRP KIT (US TRAY)

    MDR report key: 19623111 · Received June 27, 2024

    Report

    Report Number
    1220246-2024-06449
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    March 22, 2024
    Report Date
    March 21, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867279919
    PMA / PMN Number
    BK180180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B3, B5, H3, H6.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED ON 06/11/2024 WHERE THE FACILITY REPRESENTATIVE STATED THAT THE DATE OF THE BLOODBORNE NEEDLE STICK WAS ON (B)(6) 2024. THE INCIDENT TOOK PLACE DURING A PRP BLOOD DRAW USING THE ARTHREX ANGEL PRP KIT. AS PART OF THE KIT, WAS A WINGED INFUSION KIT THAT HAS A COVER THAT FLIPS OVER THE NEEDLE TO PROTECT THE WORKER. IN THIS INSTANCE, THE GUARD DID NOT CLICK INTO PLACE AND EXPOSED THE NEEDLE WHEN THE WORKER WAS CLEANING UP THE AREA.

    Description of Event or Problem · 0

    ON 05/29/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06580976 THAT AN ABS-10061T ARTHREX ANGEL® PRP KIT ENCOUNTERED DIFFICULTY IN CLOSING THE CAP SECURELY. THE EMPLOYEE HAD TO EXERT CONSIDERABLE FORCE TO PUSH DOWN THE CAP. UNFORTUNATELY, DURING THIS PROCESS, THE EMPLOYEE WAS NOT FULLY ATTENTIVE, AND THE NEEDLE, WHICH WAS REPORTED NOT PROPERLY SECURED, ENDED UP POKING HER LEFT THUMB. THIS INJURY REQUIRED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433077 ARTHREX ANGEL PRP KIT (US TRAY) PLATELET AND PLASMA SEPARATOR ORG ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY) UNK 00888867279919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other