BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9.5F DIGNITY DUEL LUMEN CT PORT

    MDR report key: 12023805 · Received June 18, 2021

    Report

    Report Number
    2518902-2021-00030
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 25, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJT
    UDI-DI
    00884908115567
    PMA / PMN Number
    K153238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS UNAVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE CONTRACT MANUFACTURER OF THE PORT AND LUMEN CONDUCTED A REVIEW OF THE MANUFACTURE RECORDS FOR THE LOT NUMBERS REPORTED. THEIR INVESTIGATION SHOWED THE DEVICES WERE MANUFACTURED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE LAST STEP IN THE MANUFACTURE PROCESS INCLUDES A 100% LEAK TEST. THIS TEST WOULD HAVE REVEALED A LEAK OR WEAKNESS IF IT HAD EXISTED AT THE TIME OF MANUFACTURE. WITHOUT AN EVALUATION OF THE DEVICE INVOLVED WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. POSSIBLE COMPLICATIONS LISTED IN THE INSTRUCTIONS FOR USE INCLUDE: CATHETER OR PORT RELATED SEPSIS, EXTRAVASATION, CATHETER OCCLUSION. 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

    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

    PATIENT PRESENTED TO HAVE CADD (COMPUTER-AIDED DRUG DISCOVERY) PUMP CHANGED. DIFFICULT BLOOD RETURN NOTED. SUPERIOR PORT SITE LEAKING. PORT WAS FLUSHED, DE-ACCESSED. ACCESSED INFERIOR LUMEN AND CONNECTED PUMP. ADDITIONAL INFORMATION PROVIDED BY RISK MANAGER: "DURING VISIT, THE SUPERIOR PORT SITE WAS SLIGHTLY REDDENED. SHE WAS INSTRUCTED TO GO TO THE ED IF IT GOT WORSE. THE FOLLOWING DAY, SHE WENT TO ED WITH INCREASED REDDENING AND GIVEN A COURSE OF ANTIBIOTICS FOR POSSIBLE PORT SITE INFECTION. PATIENT CONTINUES TO RECEIVED HER TREATMENTS USING THE LATERAL PORT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925518 9.5F DIGNITY DUEL LUMEN CT PORT DIGNITY DUEL LUMEN CT PORT LJT MEDICAL COMPONENTS, INC. MRDP95ADS MPMK180 S2 00884908115567

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention