BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2025-06742
- Event Type
- Malfunction
- Date Received
- August 13, 2025
- Date of Event
- August 4, 2025
- Report Date
- November 5, 2025
- 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
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS UNCONFIRMED. RECEIVED 1 OPENED LUBRI-SIL CATHETERISATION TRAY. VISUAL INSPECTION OF CATHETER NOTED NO FLASHES, NICKS OR SHARPS ON THE CATHETER. CATHETER WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND ASYMMETRICAL BALLOON WAS PRESENT. WITH THE RETURNED SYRINGE ATTACHED THE BALLOON PASSIVELY DEFLATED 6ML IN 5 MINUTES. CATHETER WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) WITH SECOND RETURN SYRINGE AND ASYMMETRICAL BALLOON WAS PRESENT. WITH THE RETURNED SYRINGE ATTACHED THE BALLOON PASSIVELY DEFLATED 1ML IN 5 MINUTES. CATHETER WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) WITH IN HOUSE AND ASYMMETRICAL BALLOON WAS PRESENT. WITH THE RETURNED SYRINGE ATTACHED THE BALLOON PASSIVELY DEFLATED 10ML IN 5 MINUTES: 2MINUTES 20 SECONDS. NO BALLOON RUPTURE WAS PRESENT. THE REPORTED EVENT IS UNCONFIRMED; A LABELING REVIEW IS NOT REQUIRED. THE REPORTED EVENT IS UNCONFIRMED, A DHR REVIEW IS NOT REQUIRED. CORRECTION: D, 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.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. 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: DIRECTIONS FOR USE: 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. 1. OPEN OUTER WHITE WRAPPING TO PREPARE STERILE FIELD AND PLACE UNDERPAD BENEATH PATIENT, PLASTIC SIDE DOWN. 2. IF PATIENT HAS A CATHETER IN-SITU 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, RESEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION. WAIT AT LEAST 30 SECONDS FOR DEFLATION. IF PERMITTED BY LOCAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE AS DIRECTED BY LOCAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. 3. PUT ON GLOVES, COVER PATIENT WITH FENESTRATED DRAPE WITH OPEN EXPOSING LOCATION WHERE CATHETER WILL BE INSERTED, AND PLACE THE APRON ON YOURSELF. 4. USING THE TWO (2) SYRINGES, MARKED FOR CLEANSING PURPOSES ONLY, DISPENSE THE WATER ONTO THREE (3) GAUZE SQUARES. PREPARE THE PATIENT BY WIPING DOWN THE CATHETER INSERTION SITE WITH THE SATURATED GAUZE SQUARES. DRY PATIENT WITH THE REMAINING TWO (2) GAUZE SQUARES. NOTE: DO NOT USE THIS SYRINGE TO INFLATE THE CATHETER BALLOON. 5. PREPARE THE LUBRICATING GEL SYRINGE BY REMOVING THE CAP FROM THE SYRINGE TIP. 6. FOR EASING WITH THE INSERTION OF THE CATHETER INTO THE PATIENT DISPENSE THE LUBRICATING GEL INTO THE URETHRA (ACCORDING TO LOCAL PROTOCOL). 7. REMOVE TOP TRAY AND OPEN PLASTIC POUCH (SLEEVE) SURROUNDING THE CATHETER. 8. PROCEED WITH CATHETERISATION ACCORDING TO LOCAL PROTOCOL. TO INFLATE CATHETER, SIMPLY INSERT TIP OF STERILE WATER-FILLED SYRINGE GENTLY INTO VALVE (DO NOT OVERPENETRATE) AND DEPRESS PLUNGER. INSTILL ENTIRE AMOUNT OF STERILE WATER - 10 ML. 9. ATTACH STATLOCK FOLEY STABILISATION DEVICE TO THE BIFURCATION (Y-SHAPE) OF THE FOLEY CATHETER (STATLOCK FOLEY STABILISATION DEVICE CAN BE USED FOR UP TO 7 DAYS) AND APPLY. (REFER TO THE INSTRUCTIONS FOR USE PROVIDED WITH THE STATLOCK FOLEY STABILISATION DEVICE POUCH FOR MORE DETAILS). 10. IF THE PROCEDURE PACK INCLUDES A LEG BAG, UTILISE THE LEG STRAPS PROVIDED TO SECURE THE LEG BAG TO THE PATIENTS LEG, MAKING SURE NOT TO AFFECT CIRCULATION OR DRAINAGE OF URINE. 11. ENSURE CATHETER AND DRAINAGE BAG TUBING IS KINK FREE AND DRAINAGE BAG IS POSITIONED BELOW THE BLADDER TO ENSURE URINE IS FLOWING FREELY. PERIODIC INSPECTION OF THIS SYSTEM SHOULD BE MADE TO ENSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, FURTHER INVESTIGATION SHOULD BE TAKEN IN LINE WITH LOCAL PROTOCOL. INSTRUCTIONS FOR USE FOR THE NEEDLE-FREE SAMPLING: 1. KINK THE DRAINAGE TUBING AT A MINIMUM OF 5 CM BELOW THE SAMPLING PORT. 2. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. 3. USING AN ASEPTIC TECHNIQUE, POSITION THE SYRINGE (LUER SLIP TIP ONLY) IN THE CENTRE, PERPENDICULAR TO THE SURFACE OF THE PORT, AND THEN PRESS THE TIP OF THE SYRINGE INTO THE SAMPLING PORT. 4. ASPIRATE THE DESIRED VOLUME AND THEN REMOVE THE SYRINGE. 5. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. 6. UNKINK THE TUBING AND SEND THE CORRECTLY LABELLED SPECIMEN TO THE LABORATORY. CORRECTION: D. 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, BEFORE USE SPLIT IN THE BALLOON OF THE FOLEY CATHETERS HAD BEEN FOUND FOR THE SAME BATCH. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 07AUG2025, STATED THAT 8 CATHETERS HAD BEEN AFFECTED. CUSTOMER HAD ONGOING ISSUES FOR THE PAST FEW WEEKS WITH APPROXIMATELY 10 LUBRISIL TRAYS SHOWED A FAULT. THE FAULTS HAD RANGED FROM DEFLATING BALLOONS AND SHARP PARTS ON THE TIPS OF THE CATHETERS. CUSTOMER HAD UPLIFTED 30 TRAYS FROM THE UNIT AND TESTED 8. ONLY ONE OUT OF THE 8 TESTED WHICH HAD A FAULTY VALVE. THIS RESULTED IN LEAKING FROM THE VALVE AND SUBSEQUENT DEFLATION OF THE BALLOON. UNFORTUNATELY, THERE HAD ONLY BEEN ONE OTHER FAULTY CATHETER WHICH HAS BEEN SAVED AND WAS STILL ON THE UNIT WAITING TO BE COLLECTED FOR INSPECTION THROUGH THE COMPLAINTS PROCESS. ALL FAULTY TRAYS ARE FROM THE SAME BATCH NUMBER.
IT WAS REPORTED THAT, BEFORE USE SPLIT IN THE BALLOON OF THE FOLEY CATHETERS HAD BEEN FOUND FOR THE SAME BATCH. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 07AUG2025, STATED THAT 8 CATHETERS HAD BEEN AFFECTED. CUSTOMER HAD ONGOING ISSUES FOR THE PAST FEW WEEKS WITH APPROXIMATELY 10 LUBRISIL TRAYS SHOWED A FAULT. THE FAULTS HAVE RANGED FROM DEFLATING BALLOONS AND SHARP PARTS ON THE TIPS OF THE CATHETERS. CUSTOMER HAD UPLIFTED 30 TRAYS FROM THE UNIT AND TESTED 8. ONLY ONE OUT OF THE 8 TESTED WHICH HAD A FAULTY VALVE. THIS RESULTED IN LEAKING FROM THE VALVE AND SUBSEQUENT DEFLATION OF THE BALLOON. UNFORTUNATELY, THERE HAD ONLY BEEN ONE OTHER FAULTY CATHETER WHICH HAS BEEN SAVED AND WAS STILL ON THE UNIT WAITING TO BE COLLECTED FOR INSPECTION THROUGH THE COMPLAINTS PROCESS. ALL FAULTY TRAYS ARE FROM THE SAME BATCH NUMBER.
IT WAS REPORTED THAT, BEFORE USE SPLIT IN THE BALLOON OF THE FOLEY CATHETERS HAD BEEN FOUND FOR THE SAME BATCH. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 07AUG2025, STATED THAT 8 CATHETERS HAD BEEN AFFECTED. CUSTOMER HAD ONGOING ISSUES FOR THE PAST FEW WEEKS WITH APPROXIMATELY 10 LUBRISIL TRAYS SHOWED A FAULT. THE FAULTS HAD RANGED FROM DEFLATING BALLOONS AND SHARP PARTS ON THE TIPS OF THE CATHETERS. CUSTOMER HAD UPLIFTED 30 TRAYS FROM THE UNIT AND TESTED 8. ONLY ONE OUT OF THE 8 TESTED WHICH HAD A FAULTY VALVE. THIS RESULTED IN LEAKING FROM THE VALVE AND SUBSEQUENT DEFLATION OF THE BALLOON. UNFORTUNATELY, THERE HAD ONLY BEEN ONE OTHER FAULTY CATHETER WHICH HAS BEEN SAVED AND WAS STILL ON THE UNIT WAITING TO BE COLLECTED FOR INSPECTION THROUGH THE COMPLAINTS PROCESS. ALL FAULTY TRAYS ARE FROM THE SAME BATCH NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 763266 | BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER | SILICONE FOLEY CATHETER | EZL | C.R. BARD INC. (COVINGTON) -1018233 | NGJY3799 | 00801741034145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |