BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

    MDR report key: 15899943 · Received December 1, 2022

    Report

    Report Number
    1018233-2022-09179
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    November 16, 2022
    Report Date
    February 16, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741040740
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿POOR INTERFACES WITH CONNECTIONS¿. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. DIRECTIONS FOR USE: 1. WASH HANDS. 2. REMOVE PROTECTIVE CAP FROM DRAINAGE TUBE AND CONNECT DRAINAGE TUBE ADAPTER TO CATHETER. 3. FASTEN DRAINAGE BAG TO BEDFRAME NEAR THE FOOT OF THE BED. DO NOT ALLOW BAG TO TOUCH FLOOR. IMPORTANT: HANG DRAINAGE TUBE IN A STRAIGHT FASHION FROM BEDSIDE TO DRAINAGE BAG. IF DRAINAGE BAG IS PLACED EVEN WITH PATIENT¿S HIP, COIL TUBING ALONGSIDE PATIENT. TUBING SHOULD BE DRAPED OVER PATIENT¿S LEG. 4. CHECK THAT URINE IS DRAINING INTO BAG. 5. TO EMPTY BAG: A. REMOVE OUTLET TUBE FROM HOUSING. B. RELEASE CLAMP AND EMPTY BAG. C. WHEN BAG IS EMPTY, RETURN CLAMP TO CLOSED POSITION AND REPLACE TUBE IN HOUSING. NOTE: IF SPECIMEN IS REQUIRED, SEE DIRECTIONS FOR OBTAINING URINE SAMPLE. 6. WASH HANDS. 7. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS." THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INITIALLY CUSTOMER HAS BEEN USING 802002 DRAIN BAG AS IT WAS DISCONTINUED CUSTOMER WAS PROVIDED WITH 802001 DRAIN BAG. IT WAS REPORTED THAT THE DRAIN BAG WAS CLOGGED. REPRESENTATIVE EXPLAINED THAT 802001 IS THE EXACT REPLACEMENT OF 802002. ALSO STATED THAT IF THE BAG WAS CLOGGED IT COULD HAVE BEEN DUE TO SEDIMENTS AND BRIEFED THAT THERE IN NO CHANGE IN FUNCTIONALITY OF THE 802001 DRAIN BAG. CUSTOMER ALSO REPORTED THAT THE DRAIN BAG WAS LEAKING EVERYWHERE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INITIALLY CUSTOMER HAS BEEN USING 802002 DRAIN BAG AS IT WAS DISCONTINUED CUSTOMER WAS PROVIDED WITH 802001 DRAIN BAG. IT WAS REPORTED THAT THE DRAIN BAG WAS CLOGGED. REPRESENTATIVE EXPLAINED THAT 802001 IS THE EXACT REPLACEMENT OF 802002. ALSO STATED THAT IF THE BAG WAS CLOGGED IT COULD HAVE BEEN DUE TO SEDIMENTS AND BRIEFED THAT THERE IN NO CHANGE IN FUNCTIONALITY OF THE 802001 DRAIN BAG. CUSTOMER ALSO REPORTED THAT THE DRAIN BAG WAS LEAKING EVERYWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255032 BARDIA® CLOSED SYSTEM URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 802001 UNK 00801741040740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other