BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1622G LTX CATH 5CC 2-WAY 22FR

    MDR report key: 16646844 · Received March 30, 2023

    Report

    Report Number
    9611712-2023-00119
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 2, 2023
    Report Date
    April 28, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KOD
    UDI-DI
    10192253026177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WHEN THE SAMPLE WAS INFLATED WITH 10ML OF WATER AS RECOMMENDED BY THE SPECIFICATION, A LEAK IN THE BALLOON WAS OBSERVED. A ROOT CAUSE ANALYSIS INDICATED THAT THIS ISSUE OCCURRED AS A RESULT OF LOW SDT OF REINFORCEMENT LATEX WHICH CAUSES WEAK LATEX PROPERTIES AND BONDING. ACTIONS HAVE BEEN TAKEN TO ADDRESS THE REPORTED CONDITION. ALL INFORMATION RECEIVED WILL BE USED FOR FURTHER TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THE DEVICE WAS MANUFACTURED BETWEEN SEPTEMBER 27, 2021 AND FEBRUARY 24, 2022. A SAMPLE WAS NOT RECEIVED FOR THE INVESTIGATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE REPORTED CONDITION AND DETERMINE THE ROOT CAUSE. IF A SAMPLE IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED, AND THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CATHETER WHICH WAS USED AS A SUPRAPUBIC TUBE FELL OUT OF THE PATIENT. THE CATHETER HAD A LEAK IN THE BALLOON. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION PROVIDED ON MARCH 07, 2023 THE PATIENT WAS AN OUTPATIENT AND THE CATHETER WAS REPLACED WITHOUT INCIDENT AFTER IT FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226660 1622G LTX CATH 5CC 2-WAY 22FR CATHETER, UROLOGICAL KOD CARDINAL HEALTH 1622 2099U15QX 10192253026177

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown