BARDEX® LUBRICATH® FOLEY CATHETER
Report
- Report Number
- 1018233-2025-02448
- Event Type
- Injury
- Date Received
- April 8, 2025
- Date of Event
- August 18, 2024
- Report Date
- July 2, 2025
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- EZC
- UDI-DI
- 00801741017513
- PMA / PMN Number
- K910846
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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.
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 BAD FIT WITH SHAFT DUE PRODUCT SIZE ISSUE/ POORLY SEATED BALLOON/BLADDER NECK INTERFACE. 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: WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE LATEX. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. USE LUER TIP SYRINGE TO INFLATE WITH STATED ML OF STERILE WATER. OR FOR PRE-FILLED PRODUCTS, REMOVE CLIP AND SQUEEZE RESERVOIR TO INFLATE WITH STATED ML OF STERILE WATER. FOR UROLOGICAL USE ONLY. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE STICK IN THE VALVE. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION. IF NECESSARY, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS. HAVE BEEN REMOVED FROM THE PATIENT. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. CORRECTION: D, E THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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.
IT WAS REPORTED THAT FOR SOME TIME NOW, THEY HAD BEEN EXPERIENCING PROBLEMS WITH URINARY CATHETERS CLOSED AND NON-CLOSED SYSTEMS, DOUBLE STREAM OR SINGLE STREAM. THIS ALSO SEEMS TO BE THE CASE IN HOME CARE, BUT NOT IN NEPHROLOGY. URINARY CATHETERS IN PATIENTS WHO HAD VERY LITTLE, OR NO HYDRATION WERE CLOGGED ALL THE TIME, WITH A LOT OF DEPOSITS AND SIGNIFICANT LEAKAGE FROM THE CATHETER. THEY REGULARLY CHANGE THE URINARY CATHETERS FOR LESS THAN 45 DAYS AFTER THEY WERE FITTED, OR EVEN SHORTLY AFTERWARDS AND INCREASE THE LOADING, WITHOUT SATISFACTORY RESULTS. TODAY, THEY CHANGED A CH 20 CLOSED SYSTEM URINARY CATHETER IN A PATIENT WHO WAS RECEIVING LITTLE HYDRATION AND LOW SUBCUTANEOUS HYDRATION, WITH SIGNIFICANT LEAKAGE FROM THE URINARY CATHETER WITH WET PROTECTION. AFTER CHECKING THAT THE FOLEY CATHETER BALLOON WAS INFLATED AND RINSING 60ML FROM THE URINARY CATHETER, AGAIN SIGNIFICANT LEAKAGE IN THE AFTERNOON. THE URINARY CATHETER WAS CHANGED AND THE HOPPER INCREASED TO CH 22. THEY RECOVERED 700 ML, WHEREAS THE PREVIOUS CATHETER WAS INSERTED ON (B)(6) 2024.
IT WAS REPORTED THAT FOR SOME TIME NOW, THEY HAD BEEN EXPERIENCING PROBLEMS WITH URINARY CATHETERS CLOSED AND NON-CLOSED SYSTEMS, DOUBLE STREAM OR SINGLE STREAM. THIS ALSO SEEMS TO BE THE CASE IN HOME CARE, BUT NOT IN NEPHROLOGY. URINARY CATHETERS IN PATIENTS WHO HAD VERY LITTLE, OR NO HYDRATION WERE CLOGGED ALL THE TIME, WITH A LOT OF DEPOSITS AND SIGNIFICANT LEAKAGE FROM THE CATHETER. THEY REGULARLY CHANGE THE URINARY CATHETERS FOR LESS THAN 45 DAYS AFTER THEY WERE FITTED, OR EVEN SHORTLY AFTERWARDS AND INCREASE THE LOADING, WITHOUT SATISFACTORY RESULTS. TODAY, THEY CHANGED A CH 20 CLOSED SYSTEM URINARY CATHETER IN A PATIENT WHO WAS RECEIVING LITTLE HYDRATION AND LOW SUBCUTANEOUS HYDRATION, WITH SIGNIFICANT LEAKAGE FROM THE URINARY CATHETER WITH WET PROTECTION. AFTER CHECKING THAT THE FOLEY CATHETER BALLOON WAS INFLATED AND RINSING 60ML FROM THE URINARY CATHETER, AGAIN SIGNIFICANT LEAKAGE IN THE AFTERNOON. THE URINARY CATHETER WAS CHANGED AND THE HOPPER INCREASED TO CH 22. THEY RECOVERED 700ML, WHEREAS THE PREVIOUS CATHETER WAS INSERTED ON (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 490835 | BARDEX® LUBRICATH® FOLEY CATHETER | FOLEY CATHETER | EZC | C.R. BARD INC. (COVINGTON) -1018233 | MYFP2410 | 00801741017513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |