BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6308 2000ML DRAIN BG W SPOUT

    MDR report key: 12987516 · Received December 13, 2021

    Report

    Report Number
    9612030-2021-03120
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 24, 2021
    Report Date
    January 20, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KNX
    UDI-DI
    10884521002050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE ISSUE DESCRIBED BY THE CUSTOMER. THE DEVICE HISTORY RECORD REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. ONE USED SAMPLE WITHOUT ITS ORIGINAL PACKAGING WITH LOT NUMBER 2023121764 WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE RECEIVED SAMPLE WAS CARRIED OUT ACCORDING TO THE PROCEDURE. IN ADDITION, A FUNCTIONAL TEST WAS COMPLETED PER PROCEDURE. THE BAG WAS FILLED TO ITS MAXIMUM CAPACITY (2000 ML) WITHOUT OBSERVING ANY CONDITION THAT PREVENTED ITS FILLING THEREFORE THE REPORTED ISSUE WAS NOT CONFIRMED. AN INVESTIGATION WAS CARRIED OUT WITH THE MULTIFUNCTIONAL TEAM; ALL PROCESSES WERE REVIEWED AND ALL PROCESSES AND CONTROLS WERE FOUND TO BE PROPERLY FOLLOWED, INCLUDING PACKAGING AND ALL INSPECTIONS PERFORMED ON THE PRODUCT. NO ABNORMAL CONDITIONS WERE FOUND THAT COULD TRIGGER THE REPORTED CONDITION. BASED ON ALL AVAILABLE INFORMATION, THE REPORTED ISSUE COULD NOT BE CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED THEREFORE A CORRECTIVE AND PREVENTATIVE ACTION IS NOT REQUIRED AT THIS TIME. WE WILL CONTINUE TO MONITOR THE PROCESS, CUSTOMER COMPLAINTS AND FEEDBACK NOTIFICATIONS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY ATTACH THE BAG TO THEIR STOMA BUT THE BAG FULLY EXPANDS AT NIGHT AND WILL NOT ALLOW URINE TO GO IN. THIS STARTED IN RECENT MONTHS, AND FORCES THE PATIENT TO WAKE UP FREQUENTLY TO RELEASE THE AIR. NO FURTHER DETAILS WERE ABLE TO BE OBTAINED AS THE INITIAL REPORTER'S INFORMATION WAS NOT PROVIDED UPON INTAKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887170 6308 2000ML DRAIN BG W SPOUT COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER KNX CARDINAL HEALTH 6308 2023121764 10884521002050

    Patients

    Seq Age Sex Outcome Treatment
    1 Male