BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA REFILL KIT

    MDR report key: 19950027 · Received August 9, 2024

    Report

    Report Number
    3015537318-2024-00066
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 9, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    PTI
    PMA / PMN Number
    K213823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED. THERE WERE NO NONCONFORMANCES OR DEVIATIONS IN THE DEVICE HISTORY RECORD FOR THIS LOT. THE LOT MET ALL PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE. THE PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION. THE ULTIMATE ROOT CAUSE IS THUS UNDETERMINED. BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A REPORT FROM A HEATLHCARE PROVIDER WAS RECEIVED BY INTERA ONCOLOGY THAT DURING A REFILL OF THE INTERA 3000 HEPATIC ARTERY INFUSION PUMP USING AN INTERA REFILL KIT, THE "NEEDLE BROKE OFF FROM THE TUBING CAUSING RESIDUAL CHEMO TO LEAK FROM THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2216817 INTERA REFILL KIT HUBER NEEDLE WITH INFUSION SET PTI INTERA ONCOLOGY, INC AP07014US 23M006CT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention