BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX ACP TM DOUBLE SYRINGE

    MDR report key: 19479190 · Received June 6, 2024

    Report

    Report Number
    1220246-2024-05112
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    October 11, 2021
    Report Date
    June 6, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MANUFACTURERS EVALUATION STATES THAT - BASED ON THE PROVIDED PICTURES - IT CANNOT BE UNDERSTOOD WHAT TYPE OF PARTICLE IT COULD BE IN THE SYRINGE. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, 5 BATCH RESERVES WERE VISUALLY CHECKED AND NO FOREIGN PARTICLES CAN BE SEEN. FURTHERMORE, A REVIEW OF THE MANUFACTURING RECORDS DO NOT SHOW ANY ABNORMALITIES. THE REPORTED EVENT WAS CONFIRMED BASED ON THE PROVIDED PICTURES. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT SPECIFIC EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TREATMENT A FOREIGN BODY WAS IDENTIFIED IN THE SYRINGE. THE SURGEON HAS DISCARDED THE PLASMA AND FINISHED THE TREATMENT WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13017 ARTHREX ACP TM DOUBLE SYRINGE SYRINGE, PISTON LXH ARTHREX, INC. ARTHREX ACP TM DOUBLE SYRINGE 4224212100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown