BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2024-00744
- Event Type
- Malfunction
- Date Received
- February 14, 2024
- Date of Event
- December 28, 2023
- Report Date
- March 14, 2024
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- MJC
- PMA / PMN Number
- K984136
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT IS CONFIRMED - CAUSE UNKNOWN. PHOTO: RECEIVED (B)(4) SAMPLES. (B)(4) SAMPLES SHOWCASE AN OVERVIEW OF A 2-WAY FOLEY CATHETER WITH CUT PORTION OF INLET TUBING. (B)(4) SAMPLE SHOWCASES A PIECE OF PAPER WITH NATIVE WRITING. VISUAL: RECEIVED ONE (1) USED 2-WAY FOLEY CATHETER WITH CUT PORTION OF INLET TUBING WITHOUT ORIGINAL PACKAGING. VISUAL INSPECTION NOTED THE CATHETER BALLOON HAD BURST (MEASURING 0.2615"). NO MISSING PIECES WERE NOTED. THIS IS OUT OF SPECIFICATION PER INSPECTION PROCEDURE 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 STATE THE FOLLOWING: "WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLEUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE THE BALLOON TO BURST. 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. CAUTION: FEDERAL (U.S.A) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. 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. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100% SILICONE FOLEY CATHETERS. STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. VALVE TYPE: USER LUER SLIP SYRINGE. DO NOT USE NEEDLE. 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. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE 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 GENTLY 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 FALLS, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT THE BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. RECOMMENDED INFLATION CAPACITIES 5CC BALLOON: USE 10CC STERILE WATER 30CC BALLOON: USE 35CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES." 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. 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 THERE WERE NO PROBLEMS WITH THE FOLEY CATHETER DURING PRE-TEST IN THE OPERATING ROOM, THE BALLOON TORE AND FELL OUT IMMEDIATELY UPON INSERTION. ON VISUAL INSPECTION, IT WAS CONFIRMED THAT THE BALLOON WAS DAMAGED. WHEN THEY PUT THE DAMAGED PARTS BACK TOGETHER, THEY COULDN'T SEE ANY DAMAGE. THEY CUT THE INLET TUBE AND DISCARDED THE BAG.
IT WAS REPORTED THAT THERE WERE NO PROBLEMS WITH THE FOLEY CATHETER DURING PRE-TEST IN THE OPERATING ROOM, THE BALLOON TORE AND FELL OUT IMMEDIATELY UPON INSERTION. ON VISUAL INSPECTION, IT WAS CONFIRMED THAT THE BALLOON WAS DAMAGED. WHEN THEY PUT THE DAMAGED PARTS BACK TOGETHER, THEY COULDN'T SEE ANY DAMAGE. THEY CUT THE INLET TUBE AND DISCARDED THE BAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1380130 | BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | MJC | C.R. BARD, INC. (COVINGTON) -1018233 | NGGX3344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |