BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER

    MDR report key: 12484669 · Received September 16, 2021

    Report

    Report Number
    1018233-2021-05720
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 25, 2021
    Report Date
    March 1, 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 CONFIRMED MANUFACTURING RELATED. 1 SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "OPERATOR ERROR". A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A LABELING REVIEW IS NOT REQUIRED AS THE REPORTED EVENT IS CONFIRMED MANUFACTURING RELATED. 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 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 AND LIBERATOR MEDICAL, IT WAS STATED THAT THE PATIENT WAS EXPERIENCING PAINFUL INSERTION WITH THE USE OF INTERMITTENT CATHETER AND ALSO 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 GOING IN AS IF THE EYELETS WERE NOT SMOOTH AS EXPECTED AND STATED THAT THE EYELETS SHOULD BE MORE ROUNDED AND SMOOTH.

    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 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 AND LIBERATOR MEDICAL, IT WAS STATED THAT THE PATIENT WAS EXPERIENCING PAINFUL INSERTION WITH THE USE OF INTERMITTENT CATHETER AND ALSO THE PATIENT NEEDED TO LUBRICATE THE CATHETER EXCESSIVELY. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382535 BARDIA® COUDE OLIVE TIP URETHRAL FOLEY CATHETER URETHRAL FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 802516 NGFS2080 00801741039058

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other