BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URINARY DRAINAGE BAG

    MDR report key: 18110346 · Received November 10, 2023

    Report

    Report Number
    1018233-2023-08030
    Event Type
    Malfunction
    Date Received
    November 10, 2023
    Date of Event
    October 16, 2023
    Report Date
    December 29, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741029547
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "ERROR OF INSPECTOR". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. H3 OTHER TEXT: THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN (B)(6) 2021 BARD UNIVERSAL CATHETERIZATION TRAY WAS DISCONTINUED (LAWSON # 227022, REF 792100) AND WAS REPLACED WITH THE ITEM LISTED ABOVE. UROLOGY STAFF'S MAIN CONCERN WAS WHEN THE CATHETER WAS INSERTED, BEFORE HOOKING THE DRAINAGE BAG TUBING, THEY ENSURE URINE FLOW. THE CONTAINER WAS TOO LARGE AND SQUARE AND COULD NOT ADEQUATELY COLLECT URINE. THEY IMPROVISED BY USING A CLEAN GRADUATED CYLINDER BREAKING STERILITY. ANOTHER BARD CATHETERIZATION ITEM (LAWSON # 317827) WAS USED ON SOME UNITS IN THE REGION. CLINIC STAFF SAID THIS CONTAINER HAD SIMILAR PROBLEMS AS THE ONES THEY CURRENTLY STOCK. THE REQUEST FROM END USER STAFF FOR THE COLLECTION TRAY TO MIMIC THE OLD DISCONTINUED ITEM, SIMILAR TO THE KIT OF AN I/O CATHETER TRAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN (B)(6) 2021 BARD UNIVERSAL CATHETERIZATION TRAY WAS DISCONTINUED (LAWSON # (B)(4), REF (B)(4)) AND WAS REPLACED WITH THE ITEM LISTED ABOVE. UROLOGY STAFF'S MAIN CONCERN WAS WHEN THE CATHETER WAS INSERTED, BEFORE HOOKING THE DRAINAGE BAG TUBING, THEY ENSURE URINE FLOW. THE CONTAINER WAS TOO LARGE AND SQUARE AND COULD NOT ADEQUATELY COLLECT URINE. THEY IMPROVISED BY USING A CLEAN GRADUATED CYLINDER BREAKING STERILITY. ANOTHER BARD CATHETERIZATION ITEM (LAWSON #(B)(4)) WAS USED ON SOME UNITS IN THE REGION. CLINIC STAFF SAID THIS CONTAINER HAD SIMILAR PROBLEMS AS THE ONES THEY CURRENTLY STOCK. THE REQUEST FROM END USER STAFF FOR THE COLLECTION TRAY TO MIMIC THE OLD DISCONTINUED ITEM, SIMILAR TO THE KIT OF AN I/O CATHETER TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75263 BARD® URINARY DRAINAGE BAG DRAIN BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741029547

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other