BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHREX ANGEL BMC KIT

    MDR report key: 19522309 · Received June 12, 2024

    Report

    Report Number
    1220246-2024-05641
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    March 23, 2022
    Report Date
    June 12, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE DEVICE DAMAGE THAT WAS REPORTED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BMC PREPARATION WITH AN ANGEL SYSTEM DURING BONE MARROW ASPIRATION PROCESS A PART OF THE DEVICE BROKE OFF. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (OTHER TROCAR) BY SWITCHING THE SURGICAL TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE AVOE 11-APR-2022 IT WAS CONFIRMED THAT THE CONNECTOR DIDN`T KEEP UNDER PRESSURE EVEN AFTER CHANGING THE SYRINGE. UPDATE AVOE 12-APR-2022 IT WAS FURTHER CONFIRMED THAT NO PART OF THE DEVICE BROKE OFF. A SMALL CRACK CAUSED THE PRESSURE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183513 ARTHREX ANGEL BMC KIT PLATELET AND PLASMA SEPARATOR ORG ARTHREX, INC. ARTHREX ANGEL BMC KIT 1243115316

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown