BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA REFILL KIT

    MDR report key: 19821308 · Received July 24, 2024

    Report

    Report Number
    3015537318-2024-00062
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 27, 2024
    Report Date
    July 30, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    PTI
    PMA / PMN Number
    K213823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 23K000CT WAS REVIEWED. THERE WAS ONE NONCONFORMANCE RELATED TO EXCESSIVE ADHESIVE FOUND ON THE FEMALE LUER FOR THE NEEDLE. A 100% SORT AND AIR LEAK TEST WAS PERFORMED, NO ADDITIONAL NONCONFORMING PARTS WERE FOUND. NO OTHER NONCONFORMANCES WERE NOTED AND THERE WERE NO DEVIATIONS PERFORMED. THE LOT MET ALL PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE, INCLUDING TENSILE TEST, PRESSURE TEST, CLAMP INTEGRITY AND FLOW. THE PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION. THE ULITMATE ROOT CAUSE IS THUS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 23K000CT WAS REVIEWED. THERE WAS ONE NONCONFORMANCE RELATED TO EXCESSIVE ADHESIVE FOUND ON THE FEMALE LUER FOR THE NEEDLE. A 100% SORT AND AIR LEAK TEST WAS PERFORMED, NO ADDITIONAL NONCONFORMING PARTS WERE FOUND. NO OTHER NONCONFORMANCES WERE NOTED AND THERE WERE NO DEVIATIONS PERFORMED. THE LOT MET ALL PERFORMANCE SPECIFICATIONS PRIOR TO RELEASE, INCLUDING TENSILE TEST, PRESSURE TEST, CLAMP INTEGRITY AND FLOW. THE PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION. THE ULTIMATE ROOT CAUSE IS THUS UNDETERMINED. SUPPLEMENT IS TO ADD PATIENT INFORMATION (AS MADE AVAILABLE) FROM THE HEALTHCARE PROVIDER. 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 HEALTHCARE PROVIDER TO INTERA THAT WHEN ACCESSING AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WITH AN INTERA REFILL KIT, THE NEEDLE WAS BENT. THE CUSTOMER ALLEGES THAT THEY HAD THE SAME ISSUE WHEN OPENING ANOTHER KIT. THE HEALTHCARE PROVIDER DISPOSED OF THE DEVICES, SO THEY ARE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    A REPORT FROM A HEALTHCARE PROVIDER TO INTERA THAT WHEN ACCESSING AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP WITH AN INTERA REFILL KIT, THE NEEDLE WAS BENT. THE CUSTOMER ALLEGES THAT THEY HAD THE SAME ISSUE WHEN OPENING ANOTHER KIT. THE HEALTHCARE PROVIDER DISPOSED OF THE DEVICES, SO THEY ARE NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358231 INTERA REFILL KIT HUBER NEEDLE WITH INFUSION SET PTI INTERA ONCOLOGY, INC AP07014US 23K000CT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention