BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDAM COUDE CATHETER

    MDR report key: 12485012 · Received September 16, 2021

    Report

    Report Number
    1018233-2021-05726
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    September 1, 2021
    Report Date
    March 10, 2022
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURING-RELATED. ONE SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. AN ORANGE COUDE CATHETER WAS RETURNED. NO DISCOLORATION OR VISUAL DEFECTS WERE NOTED. THE CATHETER TIP AND COUDE INDICATOR APPEARED TO BE ALIGNED. THE COUDE TIP HAD SOME CURVE. SAMPLE MEETS SPECIFICATION PER, WHICH STATES "ACCEPT ANY CURVE UNLESS CATHETER IS COMPLETELY STRAIGHT". EYE WAS NOT NOTED TO HAVE ANY FLASHING. USING A FRENCH GAUGE THE CATHETER SIZE WAS CONFIRMED TO BE 16 FR. DEVICE MEETS SPECIFICATION, WHICH STATES "ACCEPT IF FRENCH SIZE MEASURES WITHIN PLUS OR MINUS 1 FRENCH SIZE". USING A CALIPER THE CATHETER EYES WERE MEASURED. THE EYE LENGTH AND WIDTH DO NOT MEET SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW WAS NOT REQUIRED AS REPORTED EVENT IS CONFIRMED MANUFACTURING RELATED. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD.

    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 AS 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. NO MEDICAL INTERVENTION WAS REPORTED. 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 ALSO THE PATIENT NEEDED TO LUBRICATE THE CATHETER EXCESSIVELY. NO MEDICAL INTERVENTION WAS REPORTED AND 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. THE DEVICE WAS NOT RETURNED.

    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 AS 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. NO MEDICAL INTERVENTION WAS REPORTED. 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382551 BARDAM COUDE CATHETER COUDE CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 010116 NGFR2426 00801741029875

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other