BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2025-10877
- Event Type
- Malfunction
- Date Received
- December 5, 2025
- Date of Event
- November 20, 2025
- Report Date
- April 23, 2026
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- MJC
- UDI-DI
- 00801741039843
- PMA / PMN Number
- K070582
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INITIAL REPORTER NAME: (B)(6). 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 IS CONFIRMED MANUFACTURING RELATED. THIS IS ADDRESSED BY CAPA 12182448. VISUAL EVALUATION NOTED INFLATED CATHETER WITH 10ML MBS USING RETURNED SYRINGE. DURING INFLATION, PINHOLE AT TRIFURCATION SITE FOUND MEASURING 0.015IN. THEREFORE, THE REPORTED EVENT IS CONFIRMED AND DOES NOT MEET SPECIFICATIONS. RISK REVIEW, LABELING REVIEW, AND DHR REVIEW ARE NOT REQUIRED AS EVENT HAS ALREADY BEING INVESTIGATED PER CAPA 12182448. REFER TO CAPA 12182448 FOR FURTHER DETAILS. CORRECTIONS MADE TO TAB(S) D, F, 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.
THE REPORTED EVENT IS CONFIRMED MANUFACTURING RELATED. THIS IS ADDRESSED BY CAPA 12182448. VISUAL EVALUATION NOTED INFLATED CATHETER WITH 10ML MBS USING RETURNED SYRINGE. DURING INFLATION, PINHOLE AT TRIFURCATION SITE FOUND MEASURING 0.015IN. THEREFORE, THE REPORTED EVENT IS CONFIRMED AND DOES NOT MEET SPECIFICATIONS WHICH STATES CATHETER LEAKS, VALVE LEAKS, BALLOON PERFORATION, LUMEN TO LUMEN, PREMATURELY DEFLATED AND DISLODGED BALLOON ARE NOT ALLOWED, AND MUST INFLATE AND DEFLATE WITH THE USE OF A SYRINGE. THE ROOT CAUSE FOR THIS FAILURE, PER CAPA 12182448, IS THE SILICONE INJECTED INTO THE FORMING CAVITY IS ENTERING PRE CURED, WHICH CAUSES OVERHEATING IN THE GATE AREA OR INJECTION POINT, AS A RESULT, THE BREAKING POINT BETWEEN THE GATE AND THE MOLDED PART IS NOT PROPERLY GENERATED, WHICH PREVENTS AUTOMATIC SEPARATION. THIS REQUIRES MANUAL DETACHMENT, INCREASING THE RISK OF PERFORATION AT THE ADAPTER INJECTION POINT DUE TO THE HIGH TEMPERATURE IN THE GATE CAUSED BY THE LACK OF FLOW IN THE JACKET. RISK REVIEW, LABELING REVIEW, AND DHR REVIEW ARE NOT REQUIRED AS EVENT HAS ALREADY BEING INVESTIGATED PER CAPA 12182448. CORRECTIONS: D, E. 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.
IT WAS REPORTED THAT DURING PRETEST CHECKED FOR WATER LEAKS. WATER LEAKED FROM THE FOLEY CATHETER.
IT WAS REPORTED THAT DURING PRETEST CHECKED FOR WATER LEAKS. WATER LEAKED FROM THE FOLEY CATHETER.
IT WAS REPORTED THAT DURING PRETEST CHECKED FOR WATER LEAKS. WATER LEAKED FROM THE FOLEY CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400685 | BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | MJC | C.R. BARD INC. (COVINGTON) -1018233 | NGJY4782 | 00801741039843 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |