BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.5FX24CM HEMO-CATH

    MDR report key: 11837660 · Received May 17, 2021

    Report

    Report Number
    2518902-2021-00027
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 8, 2021
    Report Date
    July 8, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    MSD
    UDI-DI
    00884908083002
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED AND NO PHOTOGRAPHS WERE PROVIDED. 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 MANUFACTURE PROCESS INCLUDES A 100% LEAK TEST IN WHICH THE DEVICE IS TESTED AT A PRESSURE OF 45 PSI. THIS TEST WOULD HAVE DETECTED ANY LEAK PRESENT AT THE TIME OF MANUFACTURE. THE DEVICE WAS IMPLANTED FOR 13 MONTHS PRIOR TO THE REPORTED ISSUE. WITHOUT AN EVALUATION OF THE DEVICE A ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING STATEMENTS: ASSURE THAT ALL AIR HAS BEEN ASPIRATED FROM THE CATHETER AND EXTENSIONS. FAILURE TO DO SO MAY RESULT IN AIR EMBOLISM. FREQUENT VISUAL INSPECTION SHOULD BE CONDUCTED TO DETECT LEAKS TO PREVENT BLOOD LOSS OR AIR EMBOLISM. 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

    AN AIR BUBBLE WAS NOTED IN EACH EXTENSION OF THE HEMO-CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731367 12.5FX24CM HEMO-CATH HEMO-CATH HEMODIALYSIS CATHETER MSD MEDICAL COMPONENTS, INC. MC101243 00884908083002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention