BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER EXEMPT

    MDR report key: 12490582 · Received September 17, 2021

    Report

    Report Number
    1018233-2021-05777
    Event Type
    Malfunction
    Date Received
    September 17, 2021
    Date of Event
    August 25, 2021
    Report Date
    February 25, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741039058
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE DEVICE MEETS SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. AN ORANGE COUDE CATHETER WAS RETURNED OPENED WITHOUT ORIGINAL PACKAGING. CATHETER COUDE INDICATOR AND TIP APPEARED ALIGNED. COUDE TIP HAD SOME CURVE, WHICH MEETS SPECIFICATION WHICH STATES "ACCEPT ANY CURVE UNLESS CATHETER IS COMPLETELY STRAIGHT". NO FLASHING OF THE CATHETER DRAINAGE EYE WAS NOTED. CATHETER MEETS VISUAL SPECIFICATION FOR ACCEPTABLE FLASH. A DHR REVIEW IS NOT REQUIRED AS THE EVENT IS UNCONFIRMED. HOWEVER, A REVIEW WAS COMPLETED BEFORE THE EVENT WAS UNCONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS THE REPORTED EVENT IS UNCONFIRMED A LABELING REVIEW IS NOT REQUIRED. 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 ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAD PAIN WHEN USING THE INTERMITTENT CATHETER. CUSTOMER BELIEVED THAT IT WAS BECAUSE OF THE EYELETS NOT BEING POLISHED AND DESCRIBED THAT THE CATHETER WAS HAVING A HARD RIDGE WHERE OTHER CATHETERS HAD A BEVELED EDGE. THIS HAD OCCURRED IN AT LEAST 10 CATHETERS. REPRESENTATIVE ADVISED THAT THESE HAD NO BURNISHED EYES OR REINFORCED TIP. IT WAS NOTED THAT THE CUSTOMER'S MEDICAL CONDITION ONLY INCLUDED RECENT PROCEDURE TO STRETCH URETHRA BUT THAT THE CUSTOMER HAD PAIN BEFORE THIS PROCEDURE AND CONTINUED TO EXPERIENCE THE SAME DISCOMFORT AFTER THE PROCEDURE. THE CUSTOMER USED ADEQUATE LUBRICANT AND COULD TELL THE MINUTE THEY WENT TO INSERT THE CATHETER IF THEY WOULD EXPERIENCE PAIN BUT PROCEEDED SLOWLY TO MINIMIZE FRICTION AND PAIN. REPRESENTATIVE ALSO ADVISED PAINFUL INSERTION SHOULD NOT BE AN ISSUE AT THIS STAGE OF THEIR EXPERIENCE WITH CATHETERIZING THEMSELVES AND SUGGESTED TRYING DIFFERENT BRAND 010116 BARD RED RUBBER COUDE TIP. PER EMAIL FROM CARDINAL HEALTH ON 26AUG2021 AND LIBERATOR MEDICAL SUPPLY ON 27AUG2021, IT WAS STATED THAT THE PATIENT WAS EXPERIENCING PAINFUL INSERTION WITH THE USE OF INTERMITTENT CATHETER AND THE PATIENT NEEDED TO LUBRICATE THE CATHETER EXCESSIVELY. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP CALL ON 01SEP2021, IT WAS REPORTED THAT THE PRODUCT 010116 WAS BETTER THAN 802516. HOWEVER, THE CUSTOMER STILL FELT THE CATHETER WAS GOING IN AS IF THE EYELETS WERE NOT SMOOTH AS EXPECTED AND STATED THAT THE EYELETS SHOULD BE MORE ROUNDED AND SMOOTHER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD PAIN WHEN USING THE INTERMITTENT CATHETER. CUSTOMER BELIEVED THAT IT WAS BECAUSE OF THE EYELETS NOT BEING POLISHED AND DESCRIBED THAT THE CATHETER WAS HAVING A HARD RIDGE WHERE OTHER CATHETERS HAD A BEVELED EDGE. THIS HAD OCCURRED IN AT LEAST 10 CATHETERS. REPRESENTATIVE ADVISED THAT THESE HAD NO BURNISHED EYES OR REINFORCED TIP. IT WAS NOTED THAT THE CUSTOMER'S MEDICAL CONDITION ONLY INCLUDED RECENT PROCEDURE TO STRETCH URETHRA BUT THAT THE CUSTOMER HAD PAIN BEFORE THIS PROCEDURE AND CONTINUED TO EXPERIENCE THE SAME DISCOMFORT AFTER THE PROCEDURE. THE CUSTOMER USED ADEQUATE LUBRICANT AND COULD TELL THE MINUTE THEY WENT TO INSERT THE CATHETER IF THEY WOULD EXPERIENCE PAIN BUT PROCEEDED SLOWLY TO MINIMIZE FRICTION AND PAIN. REPRESENTATIVE ALSO ADVISED PAINFUL INSERTION SHOULD NOT BE AN ISSUE AT THIS STAGE OF THEIR EXPERIENCE WITH CATHETERIZING THEMSELVES AND SUGGESTED TRYING DIFFERENT BRAND 010116 BARD RED RUBBER COUDE TIP. PER EMAIL FROM CARDINAL HEALTH ON (B)(6) 2021 AND LIBERATOR MEDICAL SUPPLY ON (B)(6) 2021, IT WAS STATED THAT THE PATIENT WAS EXPERIENCING PAINFUL INSERTION WITH THE USE OF INTERMITTENT CATHETER AND THE PATIENT NEEDED TO LUBRICATE THE CATHETER EXCESSIVELY. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP CALL ON (B)(6) 2021, IT WAS REPORTED THAT THE PRODUCT 010116 WAS BETTER THAN 802516. HOWEVER, THE CUSTOMER STILL FELT THE CATHETER WAS GOING IN AS IF THE EYELETS WERE NOT SMOOTH AS EXPECTED AND STATED THAT THE EYELETS SHOULD BE MORE ROUNDED AND SMOOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388373 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER EXEMPT URETHRAL FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 802516 NGFS2080 00801741039058

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other