BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

    MDR report key: 7610108 · Received June 18, 2018

    Report

    Report Number
    1018233-2018-02284
    Event Type
    Malfunction
    Date Received
    June 18, 2018
    Report Date
    July 9, 2018
    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
    WI, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. CONTENTS: ** RED RUBBER CATHETER, 15 FR., PRECONNECTED TO CLOSED SYSTEM COLLECTION BAG (1000ML APPROX. VOL.) POVIDONE-IODINE SWABSTICKS (3) SPECIMEN CONTAINER AND LABEL GRADUATED COLLECTION CONTAINER SYNTHETIC VINYL GLOVES (2) LUBRICANT PACKET URO-PREP¿ TRAY WITH: UNDERPAD, DRAPE STERILE: CONTENTS OF INNER WRAP ARE STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS.** BARD® URETHRAL CATHETERIZATION TRAY 772414 RED RUBBER CATHETER 15 FR. PATIENT¿S NAME ROOM NUMBER ADM. NO. DATE WITH PRECONNECTED DRAIN BAG DIRECTIONS FOR USE ON REVERSE SIDE. SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. C.R. BARD, INC. COVINGTON, GA 30014 1-800-526-4455 WWW.BARDMEDICAL.COM CATHETER MANUFACTURED IN U.S.A. MANUFACTURED IN MEXICO WARNING: 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. DIRECTIONS FOR USE: 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. 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. 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" CORRECTION: PMA/510K.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO URINE DRAINED INTO THE BAG FROM THE INTERMITTENT CATHETER. THE CATHETER WAS REMOVED, AND ALLEGEDLY FELT LIKE THERE WAS A "MEMBRANE COVERING THE EYELETS."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO URINE DRAINED INTO THE BAG FROM THE INTERMITTENT CATHETER. THE CATHETER WAS REMOVED, AND ALLEGEDLY FELT LIKE THERE WAS A "MEMBRANE COVERING THE EYELETS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450888 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER INTERMITTENT CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772414 NGCQ1755 00801741030406

    Patients

    Seq Age Sex Outcome Treatment
    1