BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONAL CATHETER¿ INTERMITTENT CATHETER

    MDR report key: 6535300 · Received May 1, 2017

    Report

    Report Number
    1018233-2017-02185
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Report Date
    February 22, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741069635
    PMA / PMN Number
    K000723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS INCONCLUSIVE, DUE TO THE SAMPLE RETURNED FOR EVALUATION WAS ALREADY USED; THEREFORE, IT COULD NOT BE EVALUATED. THE INTEGRITY OF THE TEST WOULD BE COMPROMISED AND THE RESULTS MAY NOT BE ACCURATE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿FOR UROLOGICAL USE ONLY. INTENDED FOR USE BY PATIENTS FOR BLADDER MANAGEMENT INCLUDING URINE DRAINAGE, COLLECTION AND MEASUREMENT. THE DEVICES ARE PASSED TO THE URINARY BLADDER VIA THE URETHRA. PLEASE CONTACT YOUR PHYSICIAN TO DETERMINE WHICH PRODUCT OPTIONS ARE BEST FOR YOU, PAYING CLOSE ATTENTION TO PRODUCT WARNINGS/PRECAUTIONS AND ADVERSE REACTIONS. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE. DO NOT REUSE. REUSE OF A SINGLE USE DEVICE INCREASES THE RISK OF CATHETER ACQUIRED URINARY TRACT INFECTIONS. WASH YOUR HANDS THOROUGHLY WITH SOAP AND WATER. PRIOR TO OPENING THE SEALED CATHETER POUCH, APPLY PRESSURE TO THE FOIL PACKET TO RELEASE THE WATER. ENSURE ALL WATER IS RELEASED FROM THE FOIL PACKET. WET THE CATHETER BY HOLDING THE PACKAGE WITH THE PRINTED SIDE UP AND TIP THE PACKAGE END-TO-END THREE TO SIX TIMES TO WET THE CATHETER. THIS MOVEMENT IS REQUIRED SO THAT THE WATER TRANSFERS BACK AND FORTH OVER THE CATHETER TO FULLY WET THE HYDROPHILIC COATING. PEEL OPEN THE PACK AT THE FUNNEL/HANDLE END JUST ENOUGH TO EXPOSE 5 CM (2¿) OF THE CATHETER, OR FOR PRODUCTS WITH AN INSERTION SLEEVE, EXPOSE THE INSERTION SLEEVE. DON¿T REMOVE THE CATHETER YET. USE THE ADHESIVE TAB AT THE FUNNEL END OF THE PACK TO STICK THE PACK TO A NEARBY VERTICAL SURFACE WHILE PREPARING TO CATHETERIZE. WASH THE AREA AROUND THE MEATUS BEFORE CATHETERIZING. WASH YOUR HANDS AGAIN. USING THE CATHETER. WITH INSERTION SLEEVE (GRIPPER): HOLD THE INSERTION SLEEVE WITH YOUR DOMINANT HAND AND SQUEEZE IT TO GRIP THE CATHETER SHAFT AS YOU REMOVE THE CATHETER FROM THE PACK. NEXT, HOLD THE CATHETER FUNNEL ABOVE THE INSERTION SLEEVE WITH YOUR OTHER HAND AND SLIDE THE INSERTION SLEEVE DOWN THE SHAFT, STOPPING AT ABOUT 6¿ FROM THE TIP. RELEASE THE FUNNEL. USING THE INSERTION SLEEVE TO HOLD THE CATHETER FIRMLY, GENTLY PASS THE TIP OF THE CATHETER INTO YOUR URETHRA UNTIL THE INSERTION SLEEVE NEARS THE MEATUS. ADVANCE THE CATHETER UNTIL URINE STARTS TO FLOW. WITHOUT INSERTION SLEEVE (GRIPPER): HOLD THE HANDLE/FUNNEL END AND REMOVE THE CATHETER FROM THE PACKAGING. GENTLY PASS THE TIP OF THE CATHETER INTO YOUR URETHRA AND ADVANCE THE CATHETER UNTIL URINE STARTS TO FLOW. TRY TO KEEP THE CATHETER STEADY UNTIL URINE STOPS FLOWING. WHEN URINE STOPS FLOWING, SLOWLY WITHDRAW THE CATHETER, STOPPING IF FLOW STARTS AGAIN, UNTIL THE LAST FEW DROPS HAVE DRAINED. FINISH BY DISPOSING OF THE CATHETER AND ITS PACKAGING. WASH YOUR HANDS WITH SOAP AND WATER" (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE'S HAVING PROBLEMS INSERTING CATHETER AND HAS MEASURED THEM AND SOME OF THEM ARE DIFFERENT DIAMETERS (TW 963131). MAY GO THROUGH 6 CATHETERS BEFORE ONE FITS. PATIENT HAS A MEASUREMENT GAGE AND WAS ABLE TO NOTE THAT THE ONES THAT FIT GO THROUGH THE 4.5 MM GAGE, THE ONES THAT DON'T FIT HIM WON'T GO THROUGH THE 4.5 BUT THEY WILL GO THROUGH THE 4.8 GAGE. HE ALSO NOTED THAT THE BIGGER ONES HAVE LESS LUBRICATION AND HE CAN FEEL THE DIFFERENCE. ON 13.04.2017: SECOND COMPLAINT OPENED UPON BMD REQUEST TO ADDRESS THE ALLEGED DECREASE IN LUBRICATION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEMS INSERTING THE CATHETER. IT WAS NOTED THAT THE BIGGER ONES HAD LESS LUBRICATION AND THE USER FELT THE DIFFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317020 PERSONAL CATHETER¿ INTERMITTENT CATHETER HYDRSIL GRIPPER KOD C.R. BARD, INC. (COVINGTON) -1018233 NGAW3440 00801741069635

    Patients

    Seq Age Sex Outcome Treatment
    1