BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2025-08975
- Event Type
- Malfunction
- Date Received
- October 10, 2025
- Date of Event
- October 2, 2025
- Report Date
- March 26, 2026
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- EZL
- UDI-DI
- 00801741034145
- PMA / PMN Number
- K984084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION. THE LABELING IS FOUND TO BE ADEQUATE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. 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.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATES: SINGLE USE ONLY. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER AND MAY CAUSE BALLOON TO BURST. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. DIRECTIONS FOR USE 14. INFLATE THE BALLOON WITH STERILE WATER TO THE VOLUME STATED ON THE INFLATION LUMEN OF THE CATHETER BY USING A WATER FILLED SYRINGE. DO NOT EXCEED RECOMMENDED CAPACITIES AS STATED ON THE INFLATION LUMEN OF THE CATHETER. NOTE: REFER TO INTENDED FILL VOLUME PRINTED ON THE CATHETER AND OR INFLATION CAP. FOR 6 FR. CATHETER, DO NOT INFLATE WITH ENTIRE PRE FILLED SYRINGE VOLUME. NOTE: USE OF LESS THAN THE RECOMMENDED VOLUME CAN RESULT IN ASYMMETRICALLY INFLATED BALLOON 15. ONCE INFLATED, GENTLY PULL CATHETER UNTIL THE INFLATED BALLOON IS SNUG AGAINST THE BLADDER NECK FOLEY CATHETER REMOVAL 5. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTIONS: D. F, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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 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.
IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED ON THE FOLEY (MATERIAL# A942212), THE BALLOON INFLATED SIDEWAYS. PATIENTS HAD BEEN CALLING BACK TO THE CLINIC THAT THE FOLEY HAD FALLEN OUT WITH NO BALLOON INFLATED. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 10DEC2025, THE REP WENT TO THE ASC A MONTH OR SO AGO AND WAS SUPPOSED TO REPORT THE FINDINGS. I HAVE CC¿D THE REP ON THIS EMAIL FOR ASSISTANCE. HERE IS THE REF#A942212 AND LOT NGKT3373. THE CENTER HAD SAMPLES IT WAS MY UNDERSTANDING THAT THE REP WAS GOING TO PICK THEM UP. THIS ALL HAPPENED THE END OF (B)(6).
IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED ON THE FOLEY (MATERIAL# A942212), THE BALLOON INFLATED SIDEWAYS. PATIENTS HAD BEEN CALLING BACK TO THE CLINIC THAT THE FOLEY HAD FALLEN OUT WITH NO BALLOON INFLATED.
IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED ON THE FOLEY (MATERIAL A942212), THE BALLOON INFLATED SIDEWAYS. PATIENTS HAD BEEN CALLING BACK TO THE CLINIC THAT THE FOLEY HAD FALLEN OUT WITH NO BALLOON INFLATED. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 10DEC2025, THE REP WENT TO THE ASC A MONTH OR SO AGO AND WAS SUPPOSED TO REPORT THE FINDINGS. I HAVE CC¿D THE REP ON THIS EMAIL FOR ASSISTANCE. HERE IS THE REF (B)(4) AND LOT NGKT3373. THE CENTER HAD SAMPLES IT WAS MY UNDERSTANDING THAT THE REP WAS GOING TO PICK THEM UP. THIS ALL HAPPENED THE END OF SEPTEMBER BEGINNING OF OCTOBER.
IT WAS REPORTED THAT WHEN THE BALLOON WAS INFLATED ON THE FOLEY (MATERIAL# A942212), THE BALLOON INFLATED SIDEWAYS. PATIENTS HAD BEEN CALLING BACK TO THE CLINIC THAT THE FOLEY HAD FALLEN OUT WITH NO BALLOON INFLATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144311 | BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | EZL | C.R. BARD INC. (COVINGTON) -1018233 | NGKT3373 | 00801741034145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |