BARDIA ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2020-05766
- Event Type
- Injury
- Date Received
- September 9, 2020
- Report Date
- December 14, 2020
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZL
- UDI-DI
- 00801741039171
- PMA / PMN Number
- K040504
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "MATERIALS OF CONSTRUCTION ARE NOT BIOCOMPATIBLE/IMPROPER INSTALLATION OF THE CATHETER". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. STERILE: UNLESS PACKAGE IS OPENED OR DAMAGED. WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE SILICONE AND MAY CAUSE BALLOON TO BURST. 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 SYRINGE. DO NOT USE NEEDLE. RECOMMENDED INFLATION CAPACITIES 5CC BALLOON: USE 10ML STERILE WATER 30CC BALLOON: USE 35ML STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100% SILICONE FOLEY CATHETERS. BARD AND BARDIA ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A 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."
IT WAS REPORTED THAT THE TWO DIFFERENT PATIENTS DEVELOPED URINARY TRACT INFECTIONS DUE TO FOLEY CATHETER CHANGE AND AN ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DUE TO SUPRAPUBIC CATHETER CHANGE, ALSO ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DURING IN-AND-OUT CATHETERIZATION FOR ROUTINE URINE SAMPLE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 24AUG2020, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE TWO DIFFERENT PATIENTS DEVELOPED URINARY TRACT INFECTIONS DUE TO FOLEY CATHETER CHANGE AND AN ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DUE TO SUPRAPUBIC CATHETER CHANGE, ALSO ANOTHER PATIENT DEVELOPED URINARY TRACT INFECTION DURING IN-AND-OUT CATHETERIZATION FOR ROUTINE URINE SAMPLE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP INFORMATION RECEIVED ON 24 AUG 2020, THE PATIENT WAS TREATED WITH ORAL ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 976558 | BARDIA ALL-SILICONE FOLEY CATHETER | CATHETER INSERTION TRAY | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | 806516 | NGYB1912 | 00801741039171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |