BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.6F DIGNITY LOW PROFILE CT PORT

    MDR report key: 11709637 · Received April 22, 2021

    Report

    Report Number
    2518902-2021-00022
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 18, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJT
    UDI-DI
    00884908031157
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED. A PHOTOGRAPH WAS PROVIDED SHOWING WHAT APPEARS TO BE A SLICE IN THE LUMEN, INDICATIVE OF BEING CUT WITH A SHARP INSTRUMENT. THE SLICE/CUT APPEARS TO BE AT AN ANGLE AND THROUGH APPROXIMATELY 3/4 OF THE LUMEN DIAMETER. AS THE LUMEN IS IMPLANTED FULLY IN THE PATIENT IT IS NOT EXPOSED TO SHARP OBJECTS. IT IS NOT KNOWN IF THE DEVICE WAS CHECKED FOR NICKS OR SMALL CUTS PRIOR TO INSERTION. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURE RECORDS FOR THE LOT NUMBER REPORTED. THEIR INVESTIGATION REVEALED THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE DEVICE WAS INSPECTED ACCORDING TO SPECIFICATION AS WELL. THIS INSPECTION INCLUDED A 100% LEAK TEST OF THE DEVICE. THIS TEST WOULD HAVE DETECTED THE LEAK IF IT HAD OCCURRED DURING THE MANUFACTURE PROCESS. WITHOUT AN EVALUATION OF THE DEVICE A ROOT CAUSE CANNOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY WAITING FOR ADDITIONAL INFORMATION. OUR INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. 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 CONTRAST MEDIUM INJECTED INTO THE RESERVOIR SHOWED LEAKAGE JUST IN THE PROXIMAL PORTION ADJACENT TO IT IN THE PECTORAL REGION, AN UPPER PATH APPARENTLY EXTERNAL TO THE CATHETER WAS ALSO OBSERVED, WITH A GREATER QUANTITY FLOWING TO THE CERVICAL REGION. THESE FINDINGS SUGGEST IMPAIRMENT OF THE RESERVOIR OR EVEN THE PROXIMAL PORTION OF THE CATHETER, WHICH MAY BE RELATED TO OBSTRUCTION, FRACTURE OR EVEN DISCONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602796 6.6F DIGNITY LOW PROFILE CT PORT DIGNITY CT PORT LJT MEDICAL COMPONENTS, INC. MRCTI66041 MPAG120 00884908031157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention