BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2025-07409
- Event Type
- Malfunction
- Date Received
- September 3, 2025
- Date of Event
- August 26, 2025
- Report Date
- April 15, 2026
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- MJC
- UDI-DI
- 00801741025211
- PMA / PMN Number
- K984136
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT IS CONFIRMED VIA CAPA ASSOCIATED. THIS IS ADDRESSED BY CAPA 12474540. RECEIVED (10) PHOTO SAMPLES. THE PHOTO SAMPLE WAS RETURNED AND COULD NOT BE EVALUATED FOR THE REPORTED FAILURE. RECEIVED 1 ALL-SILICONE FOLEY CATHETER WITH SAMPLE PORT CONNECTOR, SYRINGE AND PACKAGING LABEL AND 2 ALL-SILICONE FOLEY CATHETERS. VERIFIED MATERIAL NUMBER 2758J14, MANUFACTURING LOT NUMBER NGJZ2837 AND BATCH NUMBER MYKQ6355.VISUAL INSPECTION NOTED NO OBVIOUS OBSERVATIONS. THE CATHETER BALLOON IS INFLATED WITH 10ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) USING RETURNED SYRINGE. HOWEVER, ASYMMETRICAL BALLOON OBSERVED WITH BALLOON CONCENTRICITY 100/0 (B)(4). THE CATHETER BALLOON DEFLATED ONLY 4ML WITHIN 5MIN. ONCE AGAIN CATHETER WAS INFLATED 10ML MBS USING IN-HOUSE SYRINGE AND IT DEFLATED 10ML WITHIN 01MIN33SEC. CATHETER 2: RECEIVED 1 ALL-SILICONE CATHETER. VERIFIED NUMBER 2758J14 AND LOT NUMBER NGJZ2837. FILLED CATHETER WITH 10ML MBS USING IN-HOUSE LUER LOCK SYRINGE. INFLATED WITH NO DIFFICULTY. ALLOWED TO REST WITH NO OBSERVED LEAKS. 10ML DEFLATED PASSIVELY AND SUCCESSFULLY IN 01MIN 01SEC. CATHETER 3: RECEIVED 1 ALL-SILICONE CATHETER. VERIFIED NUMBER 2758J14 AND LOT NUMBER NGJZ2837. CATHETER FILLED WITH 10ML MBS USING IN-HOUSE LUER LOCK SYRINGE. INFLATED WITH NO DIFFICULTY. ALLOWED TO REST WITH NO OBSERVED LEAKS. 10ML DEFLATED PASSIVELY AND SUCCESSFULLY IN 01MIN10SEC. CAPA 12474540 IDENTIFIED THE ROOT CAUSE OF THIS FAILURE AS A COMBINATION OF THREE (3) FACTORS; PROVIDED WATER SYRINGE DOES NOT MEET USER EXPECTATION FOR SMOOTH ENGAGEMENT WITH THE VALVE AND NO INSTRUCTIONS ARE PROVIDED IN THE JAPANESE IFU FOR ASPIRATING TO ASSIST IN DEFLATION, DEFLATION TIME OR TAKE OFF FORCE CRITERIA OR SPECIFICATION TO DEFLATE THE CATHETER HAS NOT BEEN DETERMINED AND IT IS UNKNOWN FOR THE CUSTOMERS, INADEQUATE PROCESS QUALIFICATION PERFORMED WITH CHANGE IN SYRINGE SUPPLIER AND MOLD CHANGE. RISK REVIEW, LABELING REVIEW, AND DHR REVIEW ARE NOT REQUIRED AS EVENT HAS ALREADY BEEN INVESTIGATED PER CAPA 12474540. REFER TO CAPA 12474540 FOR FURTHER DETAILS. CORRECTIONS MADE TO TAB D. INITIAL REPORTER COMPLETE FACILITY NAME: YAMAGUCHI PREFECTURAL SAISEIKAI SHIMONOSEKI GENERAL HOSPITAL, SOCIAL WELFARE CORPORATION ONSHI FOUNDATION SAISEIKAI BRANCH 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 IS CONFIRMED VIA CAPA ASSOCIATED. THIS IS ADDRESSED BY CAPA 12474540. THE PHOTO SAMPLE WAS RETURNED AND COULD NOT BE EVALUATED FOR THE REPORTED FAILURE. RECEIVED 1 ALL-SILICONE FOLEY CATHETER WITH SAMPLE PORT CONNECTOR, SYRINGE AND PACKAGING LABEL AND 2 ALL-SILICONE FOLEY CATHETERS. VERIFIED MATERIAL NUMBER 2758J14, MANUFACTURING LOT NUMBER NGJZ2837 AND BATCH NUMBER MYKQ6355. VISUAL INSPECTION NOTED NO OBVIOUS OBSERVATIONS. THE CATHETER BALLOON IS INFLATED WITH 10ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) USING RETURNED SYRINGE. HOWEVER, ASYMMETRICAL BALLOON OBSERVED WITH BALLOON CONCENTRICITY 100/0. THE CATHETER BALLOON DEFLATED ONLY 4ML WITHIN 5MIN. ONCE AGAIN CATHETER WAS INFLATED 10ML MBS USING IN HOUSE SYRINGE AND IT DEFLATED 10ML WITHIN 01MIN33SEC. THIS IS WITHIN SPECIFICATION PER INSPECTION PROCEDURE IP7603444, REVISION 0. 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. CAPA 12474540 IDENTIFIED THE ROOT CAUSE OF THIS FAILURE AS A COMBINATION OF THREE (3) FACTORS; PROVIDED WATER SYRINGE DOES NOT MEET USER EXPECTATION FOR SMOOTH ENGAGEMENT WITH THE VALVE AND NO INSTRUCTIONS ARE PROVIDED IN THE JAPANESE IFU FOR ASPIRATING TO ASSIST IN DEFLATION, DEFLATION TIME OR TAKE OFF FORCE CRITERIA OR SPECIFICATION TO DEFLATE THE CATHETER HAS NOT BEEN DETERMINED AND IT IS UNKNOWN FOR THE CUSTOMERS, INADEQUATE PROCESS QUALIFICATION PERFORMED WITH CHANGE IN SYRINGE SUPPLIER AND MOLD CHANGE. RISK REVIEW, LABELING REVIEW, AND DHR REVIEW ARE NOT REQUIRED AS EVENT HAS ALREADY BEEN INVESTIGATED PER CAPA 12474540. REFER TO CAPA 12474540 FOR FURTHER DETAILS. CORRECTION: D,E,F,H. 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 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.
IT WAS REPORTED THAT, DURING PRETEST WHEN CHECKING THE FOLEY CATHETER BALLOON, EVEN AFTER SUCKING WITH A SYRINGE STERILE WATER DID NOT RETURN. PER NOTIFICATION FROM INVESTIGATOR ON 13JAN2026, IT WAS REPORTED THAT ASYMMETRICAL BALLOON WAS FOUND DURING SAMPLE EVALUATION ON 03DEC2025.
IT WAS REPORTED THAT, DURING PRETEST WHEN CHECKING THE FOLEY CATHETER BALLOON, EVEN AFTER SUCKING WITH A SYRINGE STERILE WATER DID NOT RETURN. PER NOTIFICATION FROM INVESTIGATOR ON 13JAN2026, IT WAS REPORTED THAT ASYMMETRICAL BALLOON WAS FOUND DURING SAMPLE EVALUATION ON 03DEC2025.
IT WAS REPORTED THAT, DURING PRETEST WHEN CHECKING THE FOLEY CATHETER BALLOON, EVEN AFTER SUCKING WITH A SYRINGE STERILE WATER DID NOT RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404241 | BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER | SILICONE FOLEY CATHETER | MJC | C.R. BARD INC. (COVINGTON) -1018233 | MYKQ6355 | 00801741025211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |