BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSITE PI IMPLANTABLE INFUSION PORT

    MDR report key: 15548087 · Received October 6, 2022

    Report

    Report Number
    3006942524-2022-02358
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    September 23, 2022
    Report Date
    October 5, 2022
    Product Code
    LJT
    UDI-DI
    03661234017638
    PMA / PMN Number
    K122834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE POTENTIAL LOT AFFECTED IS LOT NUMBER 18050137. THE REVIEW OF THE MANUFACTURING BATCH RECORD OF THE POLYSITE 4018PI IMPLANTABLE PORT FINAL PRODUCT (LOT 18050137) DID NOT HIGHLIGHT ANY DEVIATION THAT COULD BE THE ROOT CAUSE OF THE INCIDENT. INDEED, THE SEALING OF THE PORT-CATHETER-CONNECTION RING ASSEMBLY IS VERIFIED ON 100% OF THE DEVICES MANUFACTURED BY INJECTING AIR AT A PRESSURE OF 2.2 BAR +/- 0.2 BAR FOR 1 MINUTE. ALTERATION OF THE CATHETER OR CONNECTING RING WOULD MOST LIKELY HAVE LED TO A LEAKAGE AND WOULD HAVE BEEN DETECTED. THE LEAK TEST PERFORMED ON THE (B)(4) UNITS MANUFACTURED IS IN ACCORDANCE WITH THE SPECIFICATIONS. NO DEVIATION WAS DETECTED. THE DEVICE IS IN TRANSIT FOR RETURNED TO PEROUSE MEDICAL. PEROUSE MEDICAL HASN'T BEEN INFORMED OF OTHER INCIDENTS IMPLYING THE BATCH 18050137 (POTENTIAL LOT). WE ASKED MORE INFORMATION ABOUT THE INCIDENT (DATE IMPLANTATION, DATE EXPLANTATION, VENOUS ACCESS ROUTES, IMPLANTATION AND EXPLANTATION REPORTS, COPY OF X-RAY PICTURES FOR IMPLANTATION AND OBSERVATION OF EVENT, THE CONSEQUENCES FOR THE PATIENT). WE ARE WAITING FOR THE DEVICE IN ORDER TO PERFORM A TECHNICAL INVESTIGATION.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL CALLED IN AND STATED THEY HAD PLACED A PORT FOR A CANCER PATIENT, AND NOTICED AFTER A YEAR THAT THERE IS SOME LEAKING. THEY REMOVED THE PORT AND REPLACED IT. THE PATIENT CONDITION WAS REPORTED AS FINE POST-PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077761 POLYSITE PI IMPLANTABLE INFUSION PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT 4018PI 18050137 03661234017638

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention