BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP

    MDR report key: 17754608 · Received September 15, 2023

    Report

    Report Number
    1018233-2023-06799
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 24, 2023
    Report Date
    October 2, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741029875
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "OUTSIDE DIAMETER IS TOO LARGE, ROUGH OR IRREGULAR SHAPE PROTRUSIONS". THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿BARD® INTERMITTENT CATHETER (LATEX). INSTRUCTIONS FOR USE: INDICATIONS FOR USE: FOR UROLOGICAL USE ONLY. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. WARNINGS: ON LATEX AND RED RUBBER CATHETERS, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO FAILURE, AND/OR TO INJURY, ILLNESS OR DEATH OF THE PATIENT. NOTE: 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. ADVERSE REACTIONS URINARY TRACT INFECTION BLEEDING FROM THE URETHRA IRRITATION OF THE URETHRA INSTRUCTIONS FOR INTERMITTENT CATHETERS: WASH YOUR HANDS THOROUGHLY WITH SOAP AND WATER. REMOVE CATHETER FROM THE PACK. POSITION YOURSELF COMFORTABLY, CLEANING THE OPENING OF THE URETHRA AND SURROUNDING AREA. GENTLY INSERT ROUNDED END OF CATHETER INTO URETHRA. WHEN URINE STOPS FLOWING, REMOVE CATHETER FROM URETHRA. DISPOSE OF CATHETER IN ACCORDANCE WITH LOCAL RULES AND REGULATIONS. WASH YOUR HANDS. CAUTION: FEDERAL (U.S.A.) LAWS RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.¿ H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    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 BD REPRESENTS ALL 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WAS CURRENTLY USING CATHETER 010116, THREE SAMPLES PROVIDED BY UROLOGIST. DURING INSERTION THE PATIENT EXPERIENCED PAIN WHEN PASSING THE PROSTATE. THEY WERE ADVISED BY UROLOGIST TO SOAK CATHETERS IN DISH DETERGENT, RINSE, AIR DRY AND REUSE. PATIENT WAS INQUIRING WHAT CAME IN KIT 4A7044. REPRESENTATIVE ADVISED PATIENT KIT 4A7044 WAS A 14FR, NOT THE 16FR THE PATIENT WAS CURRENTLY USING. SUGGESTED TALKING WITH UROLOGIST REGARDING CATHETER SIZE CHANGE. ALSO ADVISED CATHETER 010116 WAS SINGLE USE AND THEY DID NOT RECOMMEND CLEANING AND REUSING THEM. INFORMED PATIENT TOUCHLESS PLUS INTERMITTENT CATHETER SYSTEM (4A7044) CONTAINED A LUBRICATED RUBBER CATHETER, GLOVES, POVIDONE IODINE SWABS TO CLEAN THEN ANATOMY, A COLLECTION BAG AND AN UNDER PAD. NO MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WAS CURRENTLY USING CATHETER 010116, THREE SAMPLES PROVIDED BY UROLOGIST. DURING INSERTION THE PATIENT EXPERIENCED PAIN WHEN PASSING THE PROSTATE. THEY WERE ADVISED BY UROLOGIST TO SOAK CATHETERS IN DISH DETERGENT, RINSE, AIR DRY AND REUSE. PATIENT WAS INQUIRING WHAT CAME IN KIT 4A7044. REPRESENTATIVE ADVISED PATIENT KIT 4A7044 WAS A 14FR, NOT THE 16FR THE PATIENT WAS CURRENTLY USING. SUGGESTED TALKING WITH UROLOGIST REGARDING CATHETER SIZE CHANGE. ALSO ADVISED CATHETER 010116 WAS SINGLE USE AND THEY DID NOT RECOMMEND CLEANING AND REUSING THEM. INFORMED PATIENT TOUCHLESS PLUS INTERMITTENT CATHETER SYSTEM (4A7044) CONTAINED A LUBRICATED RUBBER CATHETER, GLOVES, POVIDONE IODINE SWABS TO CLEAN THEN ANATOMY, A COLLECTION BAG AND AN UNDER PAD. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332852 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP UROLOGICAL CATHETER COUDE TIP KOD C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741029875

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other