BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2024-07833
- Event Type
- Malfunction
- Date Received
- December 9, 2024
- Date of Event
- November 19, 2024
- Report Date
- February 11, 2025
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZL
- UDI-DI
- 00801741034152
- PMA / PMN Number
- K984084
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE. RECEIVED ONE UNOPENED TRAY (A942214 LOT NGJQ0780) THAT CONTAINED THE CATHETER 175814 LOT NGJP4235. THE BALLOON WAS INFLATED WITH IN-HOUSE SYRINGE AND 10 ML OF METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER). THE BALLOON CONCENTRICITY WAS WITHIN SPECIFICATION AND THE CATHETER RESTED WITH NO LEAKS. THE IN-HOUSE SYRINGE WAS CONNECTED AND THE BALLOON DEFLATED PASSIVELY IN 1 MINUTE AND 13 SECONDS WITH NO ISSUES OR CUFFING. NO BALLOON RUPTURED WAS NOTED. THE REPORTED EVENT WAS NOT CONFIRMED IN THE REPRESENTATIVE SAMPLE; HOWEVER, FAILURE CANNOT BE UNCONFIRMED AS THE CONDITIONS OF THE ALLEGED DEFECTIVE SAMPLE ARE UNKNOWN. THE REPORTED EVENT IS CONSIDERED INCONCLUSIVE. 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: ¿PROPER TECHNIQUES FOR URINARY CATHETER INSERTION PERFORM HAND HYGIENE IMMEDIATELY BEFORE AND AFTER INSERTION INSERT URINARY CATHETERS USING ASEPTIC TECHNIQUE AND STERILE EQUIPMENT USE THE SMALLEST FOLEY CATHETER POSSIBLE, CONSISTENT WITH GOOD DRAINAGE DOCUMENT THE INDICATIONS FOR CATHETER INSERTION, DATE AND TIME OF CATHETER INSERTION, INDIVIDUAL WHO INSERTED CATHETER, AND DATE AND TIME OF CATHETER REMOVAL IN PATIENT RECORD PROPER TECHNIQUES FOR URINARY CATHETER MAINTENANCE SECURE THE FOLEY CATHETER, USE THE STATLOCK FOLEY STABILIZATION DEVICE IF PROVIDED MAINTAIN A CLOSED DRAINAGE SYSTEM BY UTILIZING PRE-CONNECTED, SEALED CATHETER-TUBING JUNCTIONS MAINTAIN UNOBSTRUCTED URINE FLOW AND KEEP THE CATHETER AND COLLECTION TUBE FREE FROM KINKING KEEP THE COLLECTION BAG BELOW THE LEVEL OF THE BLADDER OR HIPS AT ALL TIMES EMPTY THE COLLECTION BAG REGULARLY (E.G., PRIOR TO TRANSPORT) USING A SEPARATE, CLEAN COLLECTION CONTAINER FOR EACH PATIENT ROUTINE HYGIENE (E.G., CLEANSING OF THE MEATAL SURFACE DURING DAILY BATHING OR SHOWERING) IS APPROPRIATE LEAVE FOLEY CATHETER IN PLACE ONLY AS LONG AS NEEDED DIRECTIONS FOR USE WASH HANDS AND DON CLEAN GLOVES EXPLAIN PROCEDURE TO PATIENT AND OPEN PERI-CARE KIT 3. USE THE PROVIDED PACKET OF WIPES TO CLEANSE PATIENT¿S PERIURETHRAL AREA 4. REMOVE GLOVES AND PERFORM HAND HYGIENE WITH PROVIDED ALCOHOL HAND SANITIZER GEL 5. USING PROPER ASEPTIC TECHNIQUE OPEN CSR WRAP 6. DON STERILE GLOVES 7. PLACE UNDERPAD BENEATH PATIENT, PLASTIC/¿SHINY¿ SIDE DOWN NOTE: USE CAUTION TO MAINTAIN ASEPTIC TECHNIQUE 8. POSITION FENESTRATED DRAPE ON PATIENT 9. SATURATE 3 FOAM SWAB STICKS IN POVIDONE IODINE 10.ATTACH THE WATER FILLED SYRINGE TO THE INFLATION PORT NOTE: IT IS NOT NECESSARY TO PRE-TEST THE FOLEY CATHETER BALLOON 11. REMOVE FOLEY CATHETER FROM WRAP AND LUBRICATE CATHETER 12. PREPARE PATIENT WITH 3 FOAM SWAB STICKS SATURATED IN POVIDONE IODINE. USE THE NONDOMINANT HAND FOR THE GENITALIA AND THE DOMINANT HAND FOR THE SWABS NOTE: USE EACH SWAB STICK FOR ONE SWIPE ONLY FEMALE PATIENT: WITH A DOWNWARD STROKE CLEANSE THE RIGHT LABIA MINORA AND DISCARD THE SWAB. DO THE SAME FOR THE LEFT LABIA MINORA. WITH THE LAST SWABSTICK CLEANSE THE MIDDLE AREA BETWEEN THE LABIA INORA MALE PATIENT: CLEANSE THE PENIS IN A CIRCULAR MOTION STARTING AT THE URETHRAL MEATUS AND WORKING OUTWARD 13. PROCEED WITH CATHETERIZATION IN USUAL MANNER USING THE DOMINANT HAND A. WHEN CATHETER TIP HAS ENTERED BLADDER, URINE WILL BE VISIBLE IN THE DRAINAGE TUBE B. INSERT CATHETER TWO MORE INCHES AND INFLATE CATHETER BALLOON 14. INFLATE CATHETER BALLOON USING ENTIRE 10CC OF STERILE WATER PROVIDED IN THE PREFILLED SYRINGE NOTE: USE OF LESS THAN 10CC CAN RESULT IN ASYMMETRICALLY INFLATED BALLOON 15. ONCE INFLATED, GENTLY PULL CATHETER UNTIL THE INFLATED BALLOON IS SNUG AGAINST THE BLADDER NECK 16. SECURE THE FOLEY CATHETER TO THE PATIENT USE THE STATLOCK FOLEY STABILIZATION DEVICE IF PROVIDED (SEE STATLOCK FOLEY STABILIZATION DEVICE IFU) NOTE: PLEASE MAKE SURE PATIENT IS APPROPRIATE FOR USE OF STATLOCK® STABILIZATION DEVICE 17. POSITION HANGER ON BED RAIL AT THE FOOT OF THE BED NOTE: EXERCISE CARE TO KEEP BAG OFF THE FLOOR 18. USE GREEN SHEETING CLIP TO SECURE DRAINAGE TUBE TO THE SHEET. MAKE SURE TUBE IS NOT KINKED 19. INDICATE TIME AND DATE OF CATHETER INSERTION ON PROVIDED LABELS. PLACE DESIGNATED LABELS ON PATIENT CHART AND DRAINAGE SYSTEM 20. DOCUMENT PROCEDURE ACCORDING TO HOSPITAL PROTOCOL FOLEY CATHETER REMOVAL 1. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER LOCK OR SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE ¿STICK¿ IN THE VALVE 2. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY 3. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION 4. IF THE BALLOON WILL NOT DEFLATE AND IF PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL 5. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT¿. 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 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 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 DURING USE, THERE WERE 3 INCIDENTS WITH THE SURE STEP FOLEY CATHETER TRAY WITH FAULTY CATHETER, MEANING THE BALLOON WAS BROKEN. WHILE INFLATING THE FOLEY CATHETER BALLOON WITH SALINE, THE SALINE WAS LEAKING, AND THE FOLEYS CATHETER CAME OUT. ACCORDING TO THEM, IT'S THE THIRD TIME WITH DIFFERENT STAFF. LOT#NGJQ0780 AND LOT#UNK. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28NOV2024, STATED THAT NO PATIENT IMPACT AND NO MEDICAL INTERVENTION REQUIRED.
IT WAS REPORTED THAT DURING USE, THERE WERE 3 INCIDENTS WITH THE SURE STEP FOLEY CATHETER TRAY WITH FAULTY CATHETER, MEANING THE BALLOON WAS BROKEN. WHILE INFLATING THE FOLEY CATHETER BALLOON WITH SALINE, THE SALINE WAS LEAKING, AND THE FOLEYS CATHETER CAME OUT. ACCORDING TO THEM, IT'S THE THIRD TIME WITH DIFFERENT STAFF. LOT#NGJQ0780 AND LOT#UNK. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28NOV2024, STATED THAT NO PATIENT IMPACT AND NO MEDICAL INTERVENTION REQUIRED.
IT WAS REPORTED THAT DURING USE, THERE WERE 3 INCIDENTS WITH THE SURE STEP FOLEY CATHETER TRAY WITH FAULTY CATHETER, MEANING THE BALLOON WAS BROKEN. WHILE INFLATING THE FOLEY CATHETER BALLOON WITH SALINE, THE SALINE WAS LEAKING, AND THE FOLEYS CATHETER CAME OUT. ACCORDING TO THEM, IT'S THE THIRD TIME WITH DIFFERENT STAFF. LOT#NGJQ0780 AND LOT#UNK. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 28NOV2024, STATED THAT NO PATIENT IMPACT AND NO MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304436 | BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | NGJQ0780 | 00801741034152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |