BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUB-Q PORT PERITON (NO C

    MDR report key: 8822138 · Received July 24, 2019

    Report

    Report Number
    3006260740-2019-02160
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    UDI-DI
    00801741025792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. ELECTRONIC PHOTOS AND X-RAYS WERE ALSO PROVIDED FOR EVALUATION. THE INVESTIGATION WAS CONFIRMED FOR CATHETER LOCK SLEEVE DETACHMENT. A ROOT CAUSE HAS NOT BEEN DETERMINED. THE DEVICE IS LABELED FOR SINGLE USE. 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 CATH-LOCK OVER SLEEVE OF A MODEL 0603006 IMPLANTABLE PORT ALLEGEDLY DISCONNECTED . THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED TO BE A 37-YEAR-OLD FEMALE, WEIGHT WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. 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 CATH-LOCK OVER SLEEVE OF A MODEL 0603006 IMPLANTABLE PORT ALLEGEDLY DISCONNECTED . THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE ALLEGED MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED TO BE A (B)(6) YEAR-OLD FEMALE, WEIGHT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615504 SUB-Q PORT PERITON (NO C IMPLANTABLE PORT LJT BARD ACCESS SYSTEMS 0603006 RECR0172 00801741025792

    Patients

    Seq Age Sex Outcome Treatment
    1