BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX ACP TM DOUBLE SYRINGE

    MDR report key: 19484808 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05259
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 10, 2021
    Report Date
    June 7, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE DEVICE WAS RETURNED CONTAMINATED WITH BLOOD. PICTURES WERE TAKEN BUT THE DEVICE COULD NOT BE DISASSEMBLED AND EXAMINED FURTHER. NO CONTAMINATION WAS OBSERVED. THE COMPLAINT IS NOT CONFIRMED. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION OF AUTOLOGOUS PLATELET-RICH PLASMA THERE SEEMS TO BE LOOSE PIECES OF PLASTIC INSIDE THE SYRINGES. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285899 ARTHREX ACP TM DOUBLE SYRINGE SYRINGE, PISTON LXH ARTHREX, INC. ARTHREX ACP TM DOUBLE SYRINGE 4224194800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown