BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA REFILL KIT

    MDR report key: 19757764 · Received July 16, 2024

    Report

    Report Number
    3015537318-2024-00060
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 16, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    PTI
    UDI-DI
    00850014110079
    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 SUSPECT DEVICE WAS NOT MADE AVAILABLE FOR RETURN AND EVALUATION. OTHER DEVICES FROM THIS LOT HAVE BEEN PREVIOUSLY EVALUATED. THREE DEVICES FROM THE SAME LOT WERE PULLED FROM INVENTORY AND EVALUATED BY INTERA ENGINEERING. IN SUMMARY, THE ENGINEER PRESSURIZED THE CONNECTION BETWEEN THE NEEDLE AND TUBING SET AND EXERTED MAXIMUM MANUAL FORCE. NO SIGNS OF LEAKAGE WERE OBSERVED. THIS WAS REPEATED FOR A TOTAL OF 3 TIMES ON 3 DIFFERENT KITS FROM THE SAME LOT. ADDITIONAL 3RD PARTY TESTING FOR LEAKAGE WAS CONDUCTED, AND ACCEPTABLE DEVICE PERFORMANCE (WITHOUT LEAKAGE) WAS CONFIRMED. THEREFORE, THE ORIGIN OF THE COMPLAINT IS UNCONFIRMED. BLANK FIELDS IN THE MDR FORM REPRESENT UNKNOWN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT THEY HAD 'AN ONGOING ISSUE WITH LEAKING BETWEEN THE INTERA NEEDLE AND CONNECTOR SET.' HEALTHCARE PROVIDER STATED 'THE CONNECTIONS BEING VERY THOROUGHLY TIGHTENED, LEAKING PERSISTS WHEN MEDICATION IS INSTILLED. HEALTHCARE PROVIDER ASKED IF THE FEMALE END [OF THE NEEDLE] IS NOT CIRCULAR BUT STRAIGHT ON EITHER SIDE IF THIS COULD BE RESULTING IN A CONNECTION THAT'S NOT SECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2508608 INTERA REFILL KIT HUBER NEEDLE WITH INFUSION SET PTI INTERA ONCOLOGY, INC AP07014US 23J038CT 00850014110079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention