BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX® LUBRICATH® FOLEY CATHETER

    MDR report key: 21968335 · Received May 6, 2025

    Report

    Report Number
    1018233-2025-03264
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    March 7, 2025
    Report Date
    May 16, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    EZC
    UDI-DI
    00801741017506
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO THIN SAC CAUSING BY SHORT LATEX DWELL TIME, LATEX DIP SPEEDS OUT TOO SLOW AND ALSO MIGHT BE CONTRIBUTED BY USER RELATED (EXAMPLE: MISHANDLING PRODUCT OR EXPOSED TO PETROLEUM OR SHARP OBJECT). THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "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. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO THIN SAC CAUSING BY SHORT LATEX DWELL TIME, LATEX DIP SPEEDS OUT TOO SLOW AND ALSO MIGHT BE CONTRIBUTED BY USER RELATED (EXAMPLE: MISHANDLING PRODUCT OR EXPOSED TO PETROLEUM OR SHARP OBJECT). THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. 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 PATIENT EXPERIENCED FOLEY DISLODGEMENT WHEN THEY GOT HOME FROM THE FACILITY. BALLOON FAILURE ON TWO OF THE FOLEYS (PCN#0165L16 AND PCN#0165L20).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED FOLEY DISLODGEMENT WHEN THEY GOT HOME FROM THE FACILITY. BALLOON FAILURE ON TWO OF THE FOLEYS. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 09MAY2025, CUSTOMER UNFORTUNATELY WAS GIVEN THE INITIAL INFORMATION ABOUT A WEEK AFTER THE SECOND FOLEY FAILED SO THEY DID NOT HAVE ANY SPECIFIC LOT OR SERIAL NUMBERS. CUSTOMER ALSO DID NOT HAVE ANY PHOTOGRAPHS OR SAMPLES OF THE FAILED ITEM. DURING A PROSTATECTOMY PROCEDURE WHEN THE 2-WAY 20FR 5CC FOLEY WAS PLACED IN THE BLADDER, THE BALLOON BROKE OFF INTO THE BLADDER. THE DOCTOR NEEDED TO DO A CYSTOSCOPY TO FISH OUT THE PORTION OF THE BALLOON THAT WAS LEFT IN THE BLADDER. THEY WERE ABLE TO REMOVE THE MATERIAL WITH NO FURTHER HARM TO THE PATIENT (PCN# (B)(4)). THE SECOND INSTANCE WAS PLACING A SUPRAPUBIC CATHETER ON A WHEELCHAIR BOUND PATIENT. THE PROCEDURE WAS PERFORMED AND THE FOLEY WAS INFLATED. AT THE NURSING FACILITY WHERE THE PATIENT LIVES THE FOLEY FELL OUT OF THE SUPRAPUBIC INCISION AND THE PATIENT NEEDED TO BE BROUGHT BACK TO THE OPERATING ROOM AND HAVE THE PROCEDURE REPEATED (PCN# (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83406 BARDEX® LUBRICATH® FOLEY CATHETER FOLEY CATHETER EZC C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741017506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O