BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2025-00601
- Event Type
- Malfunction
- Date Received
- February 5, 2025
- Date of Event
- January 9, 2025
- Report Date
- March 14, 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 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 ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME SINCE 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. 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 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® POUCH FOR MORE DETAILS). 10. POSITION HANGER ON BEDSIDE RAIL NEAR THE FOOT OF THE BED USING SHEETING CLIP TO SECURE DRAINAGE TUBE TO SHEET. 11. THE URINE METER MAY BE EMPTIED IN TWO WAYS: A. TO EMPTY INTO THE BAG, GRASP THE BOTTOM OF THE METER AND LIFT UP. TO ENSURE THAT THE METER EMPTIES COMPLETELY, LIFTING AGAIN IS RECOMMENDED. B. TO EMPTY URINE METER INTO RECEPTACLE, TWIST GREEN PORTION OF DRAIN VALVE TO THE LEFT. TO CLOSE, TWIST GREEN PORTION OF THE DRAIN VALVE TO THE RIGHT. 12. TO EMPTY BAG: A. TO REMOVE OUTLET TUBE FROM HOUSING GENTLY SQUEEZE CONNECTOR ARMS AND PULL TUBE FROM HOUSING. B. RELEASE CLAMP AND EMPTY BAG. C. AFTER EMPTYING, RECLAMP OUTLET TUBE, AND SLIDE CONNECTOR INTO HOUSING UNTIL CONNECTOR ARMS ENGAGE. NOTE: IF SPECIMEN IS REQUIRED, SEE DIRECTIONS FOR USING URINE SAMPLE PORT. REFER TO THE FOLDED PRODUCT INSERT WITHIN THE PROCEDURE PACK FOR MORE DETAILS REGARDING THE USE OF THE URINE METER. 13. 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. 14. CATHETERS SHOULD BE REPLACED IN ACCORDANCE WITH LOCAL POLICY." 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 THERE WAS FOLEY CATHETER BALLOON FAULT. THE BALLOON DID NOT RETAINED WATER, WHICH CAUSED THE CATHETER TO FALL OUT OF URETHRA AND NOT DRAIN. THIS HAPPENED WITH 2 DEVICES IN QUICK SUCCESSION, BOTH FROM THE SAME BATCH NUMBER. THERE WERE 4 OTHER CATHETERS WHICH FAILED IN IDENTICAL WAY IN ANOTHER NUH HOSPITAL DEPARTMENT.
IT WAS REPORTED THAT THERE WAS FOLEY CATHETER BALLOON FAULT. THE BALLOON DID NOT RETAINED WATER, WHICH CAUSED THE CATHETER TO FALL OUT OF URETHRA AND NOT DRAIN. THIS HAPPENED WITH 2 DEVICES IN QUICK SUCCESSION, BOTH FROM THE SAME BATCH NUMBER. THERE WERE 4 OTHER CATHETERS WHICH FAILED IN IDENTICAL WAY IN ANOTHER NUH HOSPITAL DEPARTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48536 | BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | NGJT3665 | 00801741034145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |