BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 21805053 · Received April 9, 2025

    Report

    Report Number
    1018233-2025-02457
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 17, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741017483
    PMA / PMN Number
    K910846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. 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. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: OVER ASPIRATED, INCORRECT SYRINGE/COLLAPSE LUMEN/SAC CLOSE EYE/VALVE DAMAGE). NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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. 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 WAS RETURNED. 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. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: OVER ASPIRATED, INCORRECT SYRINGE/COLLAPSE LUMEN/SAC CLOSE EYE/VALVE DAMAGE). 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. 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 CUSTOMER PLACED A BARD LUBRICATH FOLEY CATHETER INTO PATIENT AND INSTILLED 10CC OF SALINE. UPON REMOVING, WAS UNABLE TO DEFLATE OR REMOVE NO SAMPLE FROM BALLOON. REMOVED BY CUTTING THE PORT TO REMOVE SALINE. THREW AWAY FOLEY CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CUSTOMER PLACED A BARD LUBRICATH FOLEY CATHETER INTO PATIENT AND INSTILLED 10CC OF SALINE. UPON REMOVING, WAS UNABLE TO DEFLATE OR REMOVE NO SAMPLE FROM BALLOON. REMOVED BY CUTTING THE PORT TO REMOVE SALINE. THREW AWAY FOLEY CATHETER. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 07APR2025, CUSTOMER ACTUALLY HAD 2 OF THESE SAME MALFUNCTIONS WITH THESE DEVICES SO THEY WERE NOT SURE WHICH ONE THIS WAS FOR. BOTH EVENTS HAD THE SAME LOT# AND CUSTOMER BELIEVED 1 DEVICE WAS DISCARDED, 1 DEVICE THEY BELIEVED WAS RETURNED TO THEIR SUPPLY DEPARTMENT TO BE GIVEN TO A REPRESENTATIVE. BOTH PATIENTS REQUIRED ADDITIONAL FOLEY INSERTION. NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER DID NOT RELEASE PATIENT IDENTIFIERS INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470309 BARDEX® LUBRICATH® FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD INC. (COVINGTON) -1018233 NGJX3688 00801741017483

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other