BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14F X 28CM SPLIT CATH III

    MDR report key: 11888673 · Received May 26, 2021

    Report

    Report Number
    2518902-2021-00028
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    March 2, 2021
    Report Date
    June 23, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    MSD
    UDI-DI
    00884908003666
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER WAS RETURNED FOR EVALUATION AND THE COMPLAINT WAS CONFIRMED. A VISUAL INSPECTION REVEALED A HOLE AT THE HUB TO LUMEN JUNCTION THAT IS NOT VISIBLE WITHOUT BENDING THE CATHETER. THE CATHETER LEAKED WHEN FLUSHED. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURE RECORDS FOR THE LOT NUMBER REPORTED. THEIR INVESTIGATION SHOWED THE DEVICE WAS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE PROCESS INCLUDES A 100% LEAK TEST THAT WOULD HAVE DETECTED ANY LEAK OR WEAKNESS OF THE MATERIAL IF IT EXISTED AT THE TIME OF MANUFACTURE. THE DEVICE WAS IMPLANTED FOR ALMOST 2 YEARS BEFORE THE ISSUE OCCURRED. AN IMPLANTED CATHETER IS EXPOSED TO MANY VARIABLES FOR WHICH THE MANUFACTURER HAS NO INFLUENCE OR CONTROL. WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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 THE DEVICE TO BE RETURNED FOR EVALUATION. 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

    (B)(6) 2021, THE CLAMP ON THE A SIDE WAS DAMAGED AT ANOTHER HOSPITAL (THE CLINIC THE PATIENT WENT TO FOR DIALYSIS), AND THE CLAMP WAS REPLACED. (B)(6) 2021, WHEN THEY CHECKED THE CATHETER BECAUSE THERE WERE MANY ALARMS DURING DIALYSIS AT ANOTHER HOSPITAL, IT WAS REFERRED TO THIS HOSPITAL BECAUSE THERE WAS A CRACK. WHEN THE CATHETER WAS CHECKED AT THIS HOSPITAL AFTER THIS PATIENT VISITED, A CRACK WAS FOUND AT THE CONNECTION BETWEEN THE HUB AND THE CATHETER. WHEN THE GAUZE WAS APPLIED, IT SOAKED THROUGH THE GAUZE A BIT BY BIT GRADUALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784227 14F X 28CM SPLIT CATH III SPLIT CATH III HEMODIALYSIS CATHETER MSD MEDICAL COMPONENTS, INC. ASPC28-J MCDB050 00884908003666

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention