BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2022-00233
- Event Type
- Injury
- Date Received
- January 29, 2022
- Date of Event
- January 7, 2022
- Report Date
- April 13, 2022
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZL
- UDI-DI
- 00801741034152
- PMA / PMN Number
- K984084
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿SILICONE TOO WEAK TO WITHSTAND NORMAL FORCES APPLIED DURING USE¿. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE SILICONE AND MAY CAUSE THE BALLOON TO BURST. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. UNLESS PACKAGE IS OPENED OR DAMAGED. CAUTION: DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. SINGLE USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SLIP TIP SYRINGE. DO NOT USE NEEDLE. RECOMMENDED INFLATION CAPACITIES 3CC BALLOON: USE 5CC STERILE WATER 5CC BALLOON: USE 10CC STERILE WATER 30CC BALLOON: USE 35CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR SILICONE FOLEY CATHETERS. 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. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. ALLOW THE BALLOON TO DEFLATE SLOWLY ON ITS OWN. DO NOT ASPIRATE OR MANUALLY ACCELERATE THE DEFLATION OF THE BALLOON. 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. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE.¿ 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.
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON INFLATED AND THEN IT SLIDE OUT OF THE PATIENT. UPON EXAMINING THE FOLEY CATHETER IT APPEARED THAT THE BALLOON TO THE TIP OF THE CATHETER WAS MISSING. CUSTOMER PERFORMED A CYSTOSCOPY ON THE PATIENT TO SEE IF IT COULD BE VISUALIZED IN THE BLADDER BUT WAS UNABLE TO SEE.
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON INFLATED AND THEN IT SLIDE OUT OF THE PATIENT. UPON EXAMINING THE FOLEY CATHETER IT APPEARED THAT THE BALLOON TO THE TIP OF THE CATHETER WAS MISSING. CUSTOMER PERFORMED A CYSTOSCOPY ON THE PATIENT TO SEE IF IT COULD BE VISUALIZED IN THE BLADDER BUT WAS UNABLE TO SEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1751809 | BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | 175814 | UNK | 00801741034152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |