BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPORT ISP MRI 6CF INT W SP, ATT, SL

    MDR report key: 9602521 · Received January 17, 2020

    Report

    Report Number
    3006260740-2020-00224
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Report Date
    April 1, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    UDI-DI
    00801741098956
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE MALFUNCTION IS UNKNOWN, THEREFORE THE MANUFACTURING REVIEW COULD NOT BE CONDUCTED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER, FOUR PHOTOS WERE PROVIDED FOR EVALUATION. THE INVESTIGATION IS CONFIRMED FOR 2889 DEFORMATION DUE TO COMPRESSIVE STRESS. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE IS UNKNOWN. THE DEVICE IS LABELED FOR SINGLE USE. H10: G4 H11: H6 (DEVICE CODE, METHOD, RESULTS, CONCLUSION) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 8806060 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE ONE DEVICE BELONGING TO THE SOLE MALFUNCTION IS EXPECTED TO BE RETURNED TO BD FOR EVALUATION; HOWEVER A PHOTO OF THE MALFUNCTION WAS RECIEVED. THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 8806060 IMPLANTABLE PORT ALLEGEDLY EXPERIENCED A DEFECTIVE COMPONENT. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64388 POWERPORT ISP MRI 6CF INT W SP, ATT, SL IMPLANTABLE PORT LJT BARD ACCESS SYSTEMS UNKNOWN 00801741098956

    Patients

    Seq Age Sex Outcome Treatment
    1