BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYSITE

    MDR report key: 18672313 · Received February 8, 2024

    Report

    Report Number
    2245270-2024-00015
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 8, 2024
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K122834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE MALFUNCTIONING DEVICE WAS NOT RETURNED TO VYGON, THE DETAILS OF THE MALFUNCTION WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO PEROUSE MEDICAL, WHICH IS WHERE THIS PART WAS MANUFACTURED, FOR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: THE DEVICE WAS NOT RETURNED TO PEROUSE MEDICAL FOR EVALUATION. WE CONTACTED THE CUSTOMER AND ASKED FOR MORE DETAILS ABOUT THE INCIDENT. UNFORTUNATELY, THE CUSTOMER DOESN'T HAVE THE DEFECTIVE PRODUCT TO RETURN AND IS UNABLE TO PROVIDE FURTHER DETAILS ABOUT THE INCIDENT. AS A RESULT, THIS COMPLAINT COULD NOT BE CONFIRMED, AND THE UNDERLYING CAUSE OF THE ISSUE COULD NOT BE ESTABLISHED. THE REVIEW OF THE MANUFACTURING BATCH RECORD OF THE POLYSITE 2016SPI IMPLANTABLE PORT FINAL PRODUCT (LOT 22090028) DID NOT HIGHLIGHT ANY DEVIATION THAT COULD BE THE ROOT CAUSE OF THE INCIDENT. THIS IS THE SECOND COMPLAINT REGARDING THIS PRODUCT CODE AND LOT NUMBER. BOTH COMPLAINTS WERE FROM THE SAME CUSTOMER. CORRECTIVE ACTION: DUE TO THE MISSING SAMPLE AND FURTHER INFORMATION THIS COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE OF THIS ISSUE CANNOT BE ESTABLISHED. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT.

    Description of Event or Problem · 0

    PORT WAS ERODING THROUGH THE SKIN AND HAD TO BE REMOVED.

    Description of Event or Problem · 0

    PORT WAS ERODING THROUGH THE SKIN AND HAD TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764187 POLYSITE IMPLANTABLE PORTS LJT PEROUSE MEDICAL 2016SPI 22090028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention