BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCOMPASS ANORECTAL MANOMETRY CATHETER

    MDR report key: 19497471 · Received June 10, 2024

    Report

    Report Number
    19497471
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 13, 2024
    Manufacturer
    MEDSPIRA, LLC
    Product Code
    KLA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ONCE PROCEDURE BEGAN, WE PERFORMED THE FIRST 2 MANEUVERS WITHOUT INCIDENT. THEN ON THE 3RD MANEUVER, WAS RECEIVING UNUSUAL FEEDBACK ON THE SYRINGE AND WAS UNABLE TO INFLATE THE CATHETER WITH FURTHER AIR. DR ATTEMPTED TO TRY AND WAS UNSUCCESSFUL AS WELL, SHE THEN REMOVED CATHETER. THE CATHETER WAS REPLACED, AND DR DISCARDED THE FAULTY CATHETER. THE REST OF THE PROCEDURE WENT WITHOUT EQUIPMENT MALFUNCTION. MCOMPASS MEDSPIRA CATHETER LOT# L-1106068, REF# RMD002003, PART# 9000017 EXP [REDACTED DATE], DEFECTIVE - DR DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653341 MCOMPASS ANORECTAL MANOMETRY CATHETER MONITOR, ESOPHAGEAL MOTILITY, AND TUBE KLA MEDSPIRA, LLC RMD-002-003 L-1106068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown