BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP

    MDR report key: 22496263 · Received July 14, 2025

    Report

    Report Number
    1018233-2025-05822
    Event Type
    Malfunction
    Date Received
    July 14, 2025
    Date of Event
    July 10, 2025
    Report Date
    November 5, 2025
    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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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 REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR UROLOGICAL CARE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DRAINAGE EYES TOO LARGE CAUSING INSERTION DIFFICULTY. A REVIEW OF THE DEVICE LABELLING HAS BEEN CONDUCTED FOR INVESTIGATION PURPOSES AND FOUND ADEQUATE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE, NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. CORRECTIONS: D, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STATED THEY HAD BEEN USING RED RUBBER INTERMITTENT CATHETERS, 16FR 010116 FOR SEVERAL YEARS. IT USED TO BE MANUFACTURED IN MEXICO, BUT NOW IT WAS MANUFACTURED IN MALAYSIA. PATIENT WAS NOT HAPPY WITH THE CHANGES SINCE MANUFACTURING LOCATION CHANGED. PATIENT STATED THE NEW CATHETERS HAD A LARGER EYELET WHICH SEEMED TO GET CLOGGED EASIER. IT ALSO SEEMS TO HAVE A SHARPER TIP MADE INSERTION MORE DIFFICULT. MEXICO MANUFACTURED LOT: NGGR2423. MALAYSIA MANUFACTURED LOT: NGJW1905. ADVISED BD'S MANUFACTURING PROCEDURES ARE STANDARDIZED ACROSS PLANTS AND ARE BASED UPON THE SPECIFIC PRODUCT BEING MADE. HOWEVER, THE PRODUCTS MAY APPEAR SLIGHTLY DIFFERENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STATED THEY HAD BEEN USING RED RUBBER INTERMITTENT CATHETERS, 16FR 010116 FOR SEVERAL YEARS. IT USED TO BE MANUFACTURED IN MEXICO, BUT NOW IT WAS MANUFACTURED IN MALAYSIA. PATIENT WAS NOT HAPPY WITH THE CHANGES SINCE MANUFACTURING LOCATION CHANGED. PATIENT STATED THE NEW CATHETERS HAD A LARGER EYELET WHICH SEEMED TO GET CLOGGED EASIER. IT ALSO SEEMS TO HAD A SHARPER TIP MADE INSERTION MORE DIFFICULT. MEXICO MANUFACTURED LOT: NGGR2423. MALAYSIA MANUFACTURED LOT: NGJW1905. ADVISED BD'S MANUFACTURING PROCEDURES ARE STANDARDIZED ACROSS PLANTS AND ARE BASED UPON THE SPECIFIC PRODUCT BEING MADE. HOWEVER, THE PRODUCTS MAY APPEAR SLIGHTLY DIFFERENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554869 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP COUDE CATHETER KOD C.R. BARD INC. (COVINGTON) -1018233 NGJW1905 00801741029875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other