BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

    MDR report key: 8817522 · Received July 23, 2019

    Report

    Report Number
    1018233-2019-04166
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Report Date
    August 14, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030406
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿MISSING COMPONENTS/ ACCESSORIES AND/OR NOT ACCORDING TO PROPER ASSEMBLY SEQUENCE." WITH A POTENTIAL ROOT CAUSE OF ¿INCORRECT OPERATION". THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. 1. OPEN CSR WRAP TO FORM STERILE FIELD. 2. PLACE UNDERPAD BENEATH PATIENT, PLASTIC SIDE DOWN. 3. PUT ON CUFFED GLOVES. 4. POSITION DRAPE ON PATIENT. 5. REMOVE TOP TRAY. 6. LUBRICATE CATHETER WHICH IS PRE-ATTACHED TO COLLECTION BAG. 7. BAG AND CATHETER MAY BE PLACED IN BASIN UNTIL NEEDED. 8. PREP PATIENT WITH POVIDONE-IODINE SWABSTICKS. 9. PROCEED WITH CATHETERIZATION IN USUAL MANNER. 10. TOP TRAY MAY BE PLACED ON BASIN TO HELP PREVENT SPILLAGE. 11. PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ASSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED. VOLUME ON COLLECTION CONTAINER HAS BEEN CALIBRATED WITHOUT URO-PREP¿ TRAY IN PLACE. BARD AND URO-PREP ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2010 C. R. BARD, INC. ALL RIGHTS RESERVED DIRECTIONS FOR TAKING SPECIMEN: AFTER CATHETER HAS BEEN INSERTED INTO THE BLADDER AND AN INITIAL FLOW OF URINE IS SEEN IN THE COLLECTION BAG: 1. CLAMP OFF CATHETER USING WHITE CLAMP. 2. INSERT PLASTIC TUBE (INSIDE BAG) INTO THE BACK OF THE SAMPLE DEVICE. 3. OPEN SAMPLE DEVICE OVER THE SAMPLE CONTAINER. 4. UNCLAMP CATHETER. 5. ALLOW DESIRED AMOUNT OF URINE TO DRAIN INTO COLLECTION CONTAINER. 6. CLAMP OFF CATHETER. 7. CLOSE SAMPLING DEVICE. 8. REMOVE PLASTIC TUBE FROM BACK OF SAMPLING DEVICE. 9. UNCLAMP CATHETER AND ALLOW REMAINDER OF URINE TO DRAIN INTO THE BAG. 10. IF URINE IS PLACED IN SPECIMEN JAR: A. SECURE CAP. B. LABEL SPECIMEN JAR. C. SEND SPECIMEN TO LABORATORY."

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENTS CAREGIVER THAT THE TRAY WAS MISSING THE BZK SWABSTICKS AND 5G LUBRICATING JELLY. THIS WAS NOTED PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENTS CAREGIVER THAT THE TRAY WAS MISSING THE BZK SWABSTICKS AND 5G LUBRICATING JELLY. THIS WAS NOTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608403 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER 15 FR CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772414 UNK 00801741030406

    Patients

    Seq Age Sex Outcome Treatment
    1