BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETERS, SUCTION, TRACHEOBRONCHIAL

    MDR report key: 20687978 · Received November 14, 2024

    Report

    Report Number
    1423537-2024-00305
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Report Date
    January 9, 2025
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    BSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. PLEASE NOTE: PER THE CUSTOMER, NEITHER THE PRODUCT ID OR LOT NUMBER ARE AVAILABLE. AS A RESULT, THE UDI COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THERE WERE NO PHOTOS OR PHYSICAL SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    SECTION G1 (MANUFACTURING SITE NAME AND ADDRESS): ORIGINALLY REPORTED AS CARDINAL HEALTH 200, LLC, EDIFICIO B20 CALLE #2 ZONA FRA, ALAJUELA, COSTA RICA AND SHOULD BE CARDINAL HEALTH 200 LLC, CALLE 9 SUR NO. 125 CUIDAD IND, TIJUANA, MEXICO, 22500.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE REPLOGLE WAS ATTACHED TO SUCTION, BUT SUCTION WAS NOT WORKING (EVEN THOUGH IT WAS TURNED ON). THE VENT WAS ALSO OCCLUDED BY A KINK IN TUBING AS WELL AS FLUID, SO IT WAS UNABLE TO VENT AS WELL. PER CUSTOMER, NEW REPLOGLE WAS INSERTED WITH INSTANT DRAINAGE, NEW SUCTION WAS ATTACHED TO WALL. INFANT'S ABDOMEN CONTINUED TO BE ROUND AND FULL BUT BECAME SOFT. PER CUSTOMER, NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196695 CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY CARDINAL HEALTH 200, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Female