BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYSITE

    MDR report key: 8735804 · Received June 26, 2019

    Report

    Report Number
    3006942524-2019-01180
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    March 1, 2019
    Report Date
    May 14, 2019
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K122834
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ABSENCE OF THE DEFECTIVE DEVICE AND THE BATCH NUMBER, IT WAS NOT POSSIBLE TO PERFORM A REVIEW OF THE BATCH RECORD AND A DEEPER EXPERTISE OF THE DEFECT BY THE QUALITY CONTROL LAB. CONSEQUENTLY, THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BEEN PRECISELY DETERMINED. HOWEVER, ALL POLYSITE PORTS UNDERGOES THE FOLLOWING CONTROLS ALL ALONG THE PRODUCTION OPERATIONS: THE SEALING OF THE PORT-CATHETER-CONNECTION RING ASSEMBLY IS VERIFIED ON 100% OF THE DEVICES MANUFACTURED BY INJECTING AIR AT THE 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. REGARDING THE PHENOMENON OF SEPARATION OF THE CATHETER FROM THE PORT, A POTENTIAL ROOT CAUSE WOULD BE A BAD CONNECTION OF THE CATHETER AT THE TIME OF IMPLANTATION. UNFORTUNATELY, THE FOLLOWING INFORMATION (VENOUS ACCESS ROUTES, IMPLANTATION REPORT, COPY X-RAY IMPLANTATION, COPY X-RAY EVENT), ARE NOT AVAILABLE IN THE NOTIFICATION SUMMARY TRANSMITTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO US. SO IT IS NOT POSSIBLE TO CONFIRM THIS HYPOTHESIS AND TO PRECISELY IDENTIFY THE ORIGIN OF THE INCIDENT REPORTED. FURTHERMORE, THE DIFFERENT STEPS FOR THE FIXATION OF THE CATHETER ON THE IMPLANTABLE PORT ARE PRECISELY DESCRIBED IN THE INSTRUCTION FOR USE (IFU) OF POLYSITE PORTS (SECTION IV-C: PORT INSERTION PROCEDURE OF POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT - IFU# (B)(4) AND SECTION IV-C: PORT INSERTION PROCEDURE OF POLYSITE IMPLANTABLE INFUSION PORT - IFU# (B)(4)). PRESSURE INJECTABLE INFUSION PORT OR IMPLANTABLE INFUSION PORT. BECAUSE THE PRODUCT CODE AND THE BATCH NUMBER ARE UNKNOWN, THE COMPLETE UDI IS NOT AVAILABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH (MW504737) "CATHETER PORT SEPARATION WENT TO REMOVE PORT AND THE CONNECTOR WAS NOT ATTACHED. HOWEVER, PORT CATHETER AND CONNECTOR WERE SUCCESSFULLY REMOVED WITHOUT INCIDENT". THE INFORMATION HAS BEEN RECEIVED FROM THE DISTRIBUTOR TELEFLEX ON (B)(6) 2019 AT PEROUSE MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530297 POLYSITE IMPLANTABLE INFUSION PORT LJT PEROUSE MEDICAL UNKNOW

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFORMATION PROVIDED