BARDEX® ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2024-00630
- Event Type
- Malfunction
- Date Received
- February 12, 2024
- Date of Event
- January 20, 2024
- Report Date
- February 28, 2024
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZL
- UDI-DI
- 00801741029752
- PMA / PMN Number
- K040504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT IS CONFIRMED - CAUSE UNKNOWN. RECEIVED TWO (2) PHOTO SAMPLES. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), A 2-WAY FOLEY CATHETER WITH CUT PORTION OF INLET TUBING. VISUAL INSPECTION NOTED THE CATHETER BALLOON HAD BURST MEASURING 0.4050". NO MISSING PIECES WERE NOTED. THIS IS OUT OF SPECIFICATION WHICH STATES, "BALLOON MUST NOT BE TORN". A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE PINHOLE IN BALLOON OR CUFF. 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 STATES THE FOLLOWING: "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." 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. 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 FOLEY TRAY (PCN# 9960016LR) WAS REPLACED BY FOLEY CATHETER (PCN# 165816). IT WAS STATED THAT WHEN FOLEY CATHETER WAS ABOUT TO BE REPLACED, STERILE WATER WAS DRAWN FROM THE INFLATION LUMEN AND A URINE-LIKE SUBSTANCE FLOWED, SO IT WAS REMOVED AND CHECKED AND FOUND A PIN HOLE IN THE BALLOON. OYA ICN'S OPINION IS THAT THIS MAY HAVE BEEN THE CAUSE OF THE PINHOLE. THEY CONFIRMED THAT THE BALLOON WAS DAMAGED. IT WAS STATED THAT THE OTANI INTERNATIONAL COUNCIL OF NURSES OPINION WAS THAT THIS MIGHT BE DUE TO THE USE OF METAL SASH WHEN PLACING FOLEY CATHETER. IT WAS CONFIRMED THAT THE FOLEY CATHETER BALLOON WAS DAMAGED.
IT WAS REPORTED THAT FOLEY TRAY (PCN# 9960016LR) WAS REPLACED BY FOLEY CATHETER (PCN# 165816). IT WAS STATED THAT WHEN FOLEY CATHETER WAS ABOUT TO BE REPLACED, STERILE WATER WAS DRAWN FROM THE INFLATION LUMEN AND A URINE-LIKE SUBSTANCE FLOWED, SO IT WAS REMOVED AND CHECKED AND FOUND A PIN HOLE IN THE BALLOON. OYA ICN'S OPINION IS THAT THIS MAY HAVE BEEN THE CAUSE OF THE PINHOLE. THEY CONFIRMED THAT THE BALLOON WAS DAMAGED. IT WAS STATED THAT THE OTANI INTERNATIONAL COUNCIL OF NURSES OPINION WAS THAT THIS MIGHT BE DUE TO THE USE OF METAL SASH WHEN PLACING FOLEY CATHETER. IT WAS CONFIRMED THAT THE FOLEY CATHETER BALLOON WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1297816 | BARDEX® ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | NGFR0700 | 00801741029752 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |