BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER
Report
- Report Number
- 1018233-2019-08188
- Event Type
- Malfunction
- Date Received
- December 23, 2019
- Date of Event
- June 17, 2019
- Report Date
- February 10, 2020
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- MJC
- PMA / PMN Number
- K040658
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO A "KINKED LUMEN". 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: ¿C. R. BARD, INC. COVINGTON, GA 30014 USA 1-800-526-4455 BARD LIMITED FOREST HOUSE BRIGHTON ROAD CRAWLEY, WEST SUSSEX RH11 9BP U. K. 0044 1293 527 888 ¿ BARD INFECTION CONTROL SYSTEM BARDEX® I.C. ANTI-INFECTIVE FOLEY CATHETER CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS. PK7602172 08/2005 TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP 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, RE-SEAT 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 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 MADE IN U.S.A. BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. COPYRIGHT ©2005 C. R. BARD, INC. ALL RIGHTS RESERVED. U.S. PATENT NOS. 5,320,908; 5,395,651; 5,747,178; 5,965,204; 6,224,983; AND PATENTS PENDING CANADIAN PATENT NO. 2,016,081; AUSTRALIAN PATENT NO. 642,872 PEEL TO OPEN WITH BARD® HYDROGEL AND BACTI-GUARD®* SILVER ALLOY COATING THE OCCURRENCE OF UTI IS 3.7 TIMES GREATER IN PATIENTS CATHETERIZED WITH A STANDARD CATHETER THAN IN PATIENTS CATHETERIZED WITH THE BARDEX® I.C. FOLEY CATHETER WITH BARD® HYDROGEL AND BACTI-GUARD®* SILVER ALLOY COATING (95 C.I. 2.0-6.8). BARD AND BARDEX ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. THE I.C. LOGO IS A TRADEMARK OF C. R. BARD, INC. OR AN AFFILIATE. BACTI-GUARD IS A REGISTERED TRADEMARK OF BACTIGUARD AB. *BACTI-GUARD® SILVER TECHNOLOGY IS LICENSED FROM BACTIGUARD AB. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. RECOMMENDED INFLATION CAPACITIES 3CC BALLOON: USE 5CC STERILE WATER. 5CC BALLOON: USE 10CC STERILE WATER. 30CC BALLOON: USE 35CC STERILE WATER. 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. CATHETERS SHOULD BE REPLACED IN ACCORDANCE WITH THE CDC GUIDELINE, "GUIDELINE FOR PREVENTION OF CATHETER-ASSOCIATED URINARY TRACT INFECTION." AT THE ONSET OR FIRST SIGNS OF A URINARY TRACT INFECTION, CATHETER ENCRUSTATION, OR ANY OTHER CATHETER RELATED ADVERSE EFFECT, THE CATHETER SHOULD BE REPLACED. DO NOT EXCEED RECOMMENDED CAPACITIES. STERILE: UNLESS PACKAGE IS OPENED OR DAMAGED. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. SINGLE USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. 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. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE THE BALLOON TO BURST. RELEASED" H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT TWO FOLEY CATHETER'S HAD FAULTY BALLOONS THAT WOULD NOT INFLATE. PER ADDITIONAL INFORMATION, THE FOLEY WAS INSERTED THEN THE BALLOON WAS INFLATED. THE HEALTHCARE PROVIDER PULLED GENTLY BACK TO SEAT THE FOLEY, AND THE FOLEY CAME OUT COMPLETELY. THE PATIENT REQUIRED ANOTHER CATHETER TO BE INSERTED. NO PATIENT INJURY REPORTED.
IT WAS REPORTED THAT TWO FOLEY CATHETER'S HAD FAULTY BALLOONS THAT WOULD NOT INFLATE. PER ADDITIONAL INFORMATION, THE FOLEY WAS INSERTED THEN THE BALLOON WAS INFLATED. THE HEALTHCARE PROVIDER PULLED GENTLY BACK TO SEAT THE FOLEY, AND THE FOLEY CAME OUT COMPLETELY. THE PATIENT REQUIRED ANOTHER CATHETER TO BE INSERTED. NO PATIENT INJURY REPORTED.
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 TWO FOLEY CATHETER'S HAD FAULTY BALLOONS THAT WOULD NOT INFLATE. PER ADDITIONAL INFORMATION, THE FOLEY WAS INSERTED THEN THE BALLOON WAS INFLATED. THE HEALTHCARE PROVIDER PULLED GENTLY BACK TO SEAT THE FOLEY, AND THE FOLEY CAME OUT COMPLETELY. THE PATIENT REQUIRED ANOTHER CATHETER TO BE INSERTED. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1308985 | BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER | FOLEY CATHETER | MJC | C.R. BARD, INC. (COVINGTON) -1018233 | NGBU0434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |