BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSITE

    MDR report key: 9176841 · Received October 10, 2019

    Report

    Report Number
    3004160911-2019-02438
    Event Type
    Injury
    Date Received
    October 10, 2019
    Date of Event
    August 13, 2019
    Report Date
    October 10, 2019
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    UDI-DI
    03661234017621
    PMA / PMN Number
    K122834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF MANUFACTURING BATCH RECORD OF THE POLYSITE 4018SPI IMPLANTABLE PORT FINAL PRODUCT (LOT 16050489) DID NOT HIGHLIGHT ANY DEVIATION THAT COULD BE THE ROOT CAUSE OF HE 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 HAS NOT BEEN RETURNED TO PEROUSE MEDICAL. UNFORTUNATELY , IN ABSENCE OF THE DEFECTIVE DEVICE, IT WAS NOT POSSIBLE TO PERFORM AN INVESTIGATION BY THE QUALITY CONTROL LAB. ACCORDING TO THE INFORMATION RECEIVED FROM THE FDA, THE SEPARATION OF THE CATHETER FROM THE PORT WAS DETECTED 5 DAYS AFTER IMPLANTATION, THE MOST PROBABLE ROOT CAUSE WOULD BE A BAD CONNECTION OF THE CATHETER AT THE TIME OF IMPLANTATION. HOWEVER, IN THE ABSENCE OF ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO CONFIRM THIS HYPOTHESIS AND TO PRECISELY IDENTIFY THE ORIGIN OF THE INCIDENT REPORTED. CONSEQUENTLY, THE ROOT CAUSE OF THIS COMPLAINT COULD NOT BEEN PRECISELY DETERMINED. PEROUSE MEDICAL HAS NOT BEEN INFORMED OF OTHER SIMILAR INCIDENT INVOLVING THE BATCH 16050489. 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# CD00632_001 AND SECTION IV-C: PORT INSERTION PROCEDURE OF POLYSITE IMPLANTABLE INFUSION PORT - IFU # CD00640/002). ONLY THE PRIMARY DI NUMBER HAS BEEN DOCUMENTED. THE PACKAGE DI NUMBER (B)(4). UF/IMPORTER REPORT # (B)(4) / MW5089175.

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH MW5089175 RECEIVED ON SEPTEMBER 10TH 2019: "IMPLANTABLE INFUSION PORT PLACED IN (B)(6) 2019; PLACEMENT WAS CONFIRMED BY IMAGING AND PATENCY ESTABLISH. AN ATTEMPT TO ACCESS THE PORT AT AN OUTSIDE FACILITY WAS REPORTED TO BE UNSUCCESSFUL; IMAGES SHOWED THE CATHETER AND PORT WERE SEPARATED. THE DEVICE WAS REMOVED AND REPLACED ON (B)(6) 2019."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967998 POLYSITE PRESSURE INJECTABLE IMPLANTABLE INFUSION PORT LJT PEROUSE MEDICAL 4018SPI 16050489 03661234017621

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention