BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE

    MDR report key: 21882330 · Received April 22, 2025

    Report

    Report Number
    1018233-2025-02878
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 4, 2025
    Report Date
    July 28, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741018121
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    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 BECAUSE NO SAMPLE RETURNED. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE, MANUFACTURING RELATED DUE TO OPERATOR ERROR/POOR BURN PROCESS/WRONG TECHNIC/MECHANICAL ERROR. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: INSERT FOLEY CATHETERS ONLY FOR APPROPRIATE INDICATIONS AND LEAVE IN PLACE ONLY AS LONG AS NEEDED. PROPER TECHNIQUES FOR URINARY CATHETER INSERTION: - PERFORM HAND HYGIENE IMMEDIATELY BEFORE AND AFTER INSERTION - INSERT URINARY CATHETERS USING ASEPTIC TECHNIQUE AND STERILE EQUIPMENT - USE THE SMALLEST FOLEY CATHETER POSSIBLE, CONSISTENT WITH GOOD DRAINAGE - DOCUMENT THE INDICATIONS FOR CATHETER INSERTION, DATE AND TIME OF CATHETER INSERTION, INDIVIDUAL WHO INSERTED CATHETER, AND DATE AND TIME OF CATHETER REMOVAL IN THE PATIENT RECORD PROPER TECHNIQUES FOR URINARY CATHETER MAINTENANCE: - SECURE THE FOLEY CATHETER. USE THE STATLOCK FOLEY STABILIZATION DEVICE IF PROVIDED - MAINTAIN A CLOSED DRAINAGE SYSTEM BY UTILIZING PRE-CONNECTED, SEALED CATHETER-TUBING JUNCTIONS - MAINTAIN UNOBSTRUCTED URINE FLOW AND KEEP THE CATHETER AND COLLECTION TUBE FREE FROM KINKING - KEEP THE COLLECTION BAG BELOW THE LEVEL OF THE BLADDER OR HIPS AT ALL TIMES - EMPTY THE COLLECTION BAG REGULARLY USING A SEPARATE, CLEAN COLLECTION CONTAINER FOR EACH PATIENT GENERALLY, DRAINAGE IS ACCOMPLISHED BY INSERTING THE CATHETER THROUGH THE URETHRA AND INTO THE BLADDER. HOWEVER, DRAINAGE IS SOMETIMES ACCOMPLISHED BY SUPRAPUBIC OR OTHER PLACEMENT OF THE CATHETER, SUCH AS NEPHROSTOMY TRACT. CORRECTION: D. 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 CONFIRMED ¿ MANUFACTURING RELATED. THE PRODUCT HAD CAUSED THE REPORTED FAILURE. BASED ON THE EVALUATION, IT WAS OBSERVED THAT THE ABSENCE OF A DRAINAGE EYE RESULTED IN THE BLOCKAGE OF THE DRAINAGE LUMEN. THE CATHETER WAS ABLE TO BE INFLATED AND DEFLATED WITHOUT ANY ISSUES; HOWEVER, WATER COULD NOT BE INTRODUCED THROUGH THE DRAINAGE FUNNEL. FURTHER ASSESSMENT CONFIRMED THAT THE DRAINAGE EYE WAS INDEED MISSING, LEADING TO THE OBSTRUCTION. THEREFORE, THIS COMPLAINT HAS BEEN CONFIRMED TO BE RELATED TO A MANUFACTURING ISSUE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE BURNING TIP NOT HOT ENOUGH/POOR CONNECTION OF BURNING TIP AND TRANSFORMER/WRONG OPERATOR TECHNIQUE/BURNING TIP DIRTY. A REVIEW OF THE MANUFACTURING PROCESS INDICATES THAT THE PROCESS IS CAPABLE OF PRODUCING OF THIS TYPE OF DEFECT. HOWEVER, CURRENT IN-PROCESS CONTROLS (B)(4) ARE ADEQUATE TO IDENTIFY THE DEFECT OR VERIFY THE PRODUCT INTEGRITY. THE LABELING AND INSTRUCTIONS FOR USE WERE FOUND TO BE ADEQUATE. CORRECTION: D,E,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 THEY HAD INSERTED A FOLEY CATHETER THAT WAS NOT DRAINING ANY URINE AND UPON FURTHER INSPECTION, IT DID NOT HAVE ANY DRAINAGE HOLE IN THE TIP OF THE CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY HAD INSERTED A FOLEY CATHETER THAT WAS NOT DRAINING ANY URINE AND UPON FURTHER INSPECTION, IT DID NOT HAVE ANY DRAINAGE HOLE IN THE TIP OF THE CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY HAD INSERTED A FOLEY CATHETER THAT WAS NOT DRAINING ANY URINE AND UPON FURTHER INSPECTION, IT DID NOT HAVE ANY DRAINAGE HOLE IN THE TIP OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1352273 BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE FOLEY CATHETER EZC C.R. BARD INC. (COVINGTON) -1018233 NGJX4337 00801741018121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other