BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION SET NRFIT

    MDR report key: 11395234 · Received March 1, 2021

    Report

    Report Number
    3006425876-2021-00201
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 10, 2021
    Report Date
    February 22, 2021
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN # (B)(4). A DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. ONE UNIT OF CATALOG NUMBER CA-000014-19 (NRFIT NON-STIMULATING SNAPLOCK) WAS RECEIVED FOR ANALYSIS. IT WAS OBSERVED THE FEMALE LUER TFX-001604 AND THE CATHERTER INSERTION COMPONENT TFX-000414 DISASSEMBLED. ALSO, WELD MARKS WERE OBSERVED ON BOTH COMPONENTS. CUSTOMER COMPLAINT IS CONFIRMED, THE FEMALE LUER TFX-001604 AND THE CATHERTER INSERTION COMPONENT TFX-000414 WERE FOUND DISASSEMBLED. HOWEVER, IT CANNOT BE CONFIRMED THAT SUCH DAMAGE WAS ORIGINATED DURING THE MANUFACTURE OF THE FG SINCE WELD MARKS CAN BE OBSERVED. THAT MEANS THAT THE WELD PROCESS WAS PROPERLY PERFORMED. THEREFORE, NO CORRECTIVE ACTION CAN BE ESTABLISHED. NEVERTHELESS, COMPLAINTS OF THIS TYPE WILL CONTINUE TO BE MONITORED VIA PERIODIC REVIEWS TO EVALUATE IF ANY TREND EXISTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SNAPLOCK ADAPTOR GOT DISCONNECTED FROM THE CATHETER DURING AN OPERATION. IT SEEMED THAT THE SNAPLOCK ADAPTOR GOT BROKEN. THE CATHETER AND THE ADAPTOR WERE REMOVED AND REPLACED WITH A NEW KIT TO COMPLETE THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SNAPLOCK ADAPTOR GOT DISCONNECTED FROM THE CATHETER DURING AN OPERATION. IT SEEMED THAT THE SNAPLOCK ADAPTOR GOT BROKEN. THE CATHETER AND THE ADAPTOR WERE REMOVED AND REPLACED WITH A NEW KIT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293605 EPIDURAL CATHETERIZATION SET NRFIT CAZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1