BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.6F DIGNITY LP CT PORT

    MDR report key: 11723627 · Received April 26, 2021

    Report

    Report Number
    2518902-2021-00023
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    January 30, 2021
    Report Date
    April 26, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJT
    UDI-DI
    00884908149890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE STERILIZATION CERTIFICATES FOR THE LOADS THE LOTS WERE PROCESSED ON INDICATED THAT THE LOADS PASSED ALL REQUIREMENTS OF STERILIZATION. THERE WERE NO NON-CONFORMANCES DURING THE STERILIZATION PROCESS. STERILIZATION OF MEDCOMP PRODUCT IS PERFORMED ACCORDING TO ISO STANDARD 11135 "MEDICAL DEVICES- VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION". INFECTIONS ARE THE MOST COMMON COMPLICATION AFTER IMPLANTATION OF A VENOUS PORT SYSTEM. INFECTIONS OF PORT VENOUS SYSTEMS INCLUDE POCKET AND/OR TUNNEL CELLULITIS OR THE MORE COMMON CATHETER-RELATED BLOOD STREAM INFECTIONS. INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING POTENTIAL COMPLICATION- CATHETER OR PORT RELATED SEPSIS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE FACILITY SUBMITTED A VOLUNTARY EVENT REPORT STATING THERE WERE THREE BLOODSTREAM INFECTIONS IN ONCOLOGY PATIENTS WITH PORT OVER 18 DAY PERIOD. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625485 6.6F DIGNITY LP CT PORT DIGNITY CT-PORT LJT MEDICAL COMPONENTS, INC. MRDP66PLS MNXJ480, MPFN020 00884908149890

    Patients

    Seq Age Sex Outcome Treatment
    1