BARDEX® FOLEY CATHETER SILICONE COATED
Report
- Report Number
- 1018233-2022-09358
- Event Type
- Malfunction
- Date Received
- December 7, 2022
- Date of Event
- November 22, 2022
- Report Date
- June 12, 2023
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- KOD
- PMA / PMN Number
- K922431
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE POOR SAMPLE CONDITION. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. BASED ON THE ATTACHED PHOTO, IT WAS OBSERVED THAT THE BALLOON WAS BURST. FURTHER FUNCTION TESTING COULD NOT BE PERFORMED IF ONLY BASED ON THE ATTACHED PHOTOS. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: CONTACT WITH SHARP OBJECT)/ EXPOSURE TO PETROLATUM BASED PRODUCTS/ MECHANICAL FAILURE/OPERATOR ERROR). 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: "DO NOT USE THE PRODUCT OF HAVE LATER ALLERGY. SCOPE OF APPLICATION: FOLEY CATHETER IS INTENDED FOR USE IN THE DRAINAGE OF URINE FROM THE BLADDER OF CHILDREN AND ADULTS. PRECAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION. STERILE UNLESS PACKAGE HAS BEEN OPENED OR DAMAGE. WARNING: DO NOT USE PETROLEUM SUBSTRATE LUBRICANTS WITH THE LATEX- BASED URETHRAL CATHETERS SUCH AS PETROLEUM JELLY AND LABEL LIQUID PARAFFIN, WHICH WILL DAMAGE LATEX AND MAY BURST BALLOON. WATER-SOLUBLE LUBRICANT CAN BE USED. STORAGE: CATHETERS NEED TO BE STORED AT ROOM TEMPERATURE AND KEEP AWAY FROM THE DIRECT LIGHT AND PREFERABLY STORED IN THE ORIGINAL PACKING BOX."
THE REPORTED EVENT WAS CONFIRMED ¿ CAUSE UNKNOWN. THE REPORTED FAILURE WAS ABLE TO BE REPRODUCED. VISUAL INSPECTION NOTED SAC BURST ALONG LUMEN WITHOUT MISSING PIECES. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE USER RELATED (EXAMPLE: CONTACT WITH SHARP OBJECT)/ EXPOSURE TO PETROLATUM BASED PRODUCTS/ MECHANICAL FAILURE/OPERATOR ERROR). A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE LOW LATEX VISCOSITY, SHORT LATEX DWELL TIME, LATEX DIP SPEED OUT TOO SLOW CAUSING THIN SAC. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THEREFORE NO ADDITIONAL ACTION REQUIRED AT THIS TIME. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "DO NOT USE THE PRODUCT OF HAVE LATER ALLERGY SCOPE OF APPLICATION: FOLEY CATHETER IS INTENDED FOR USE IN THE DRAINAGE OF URINE FROM THE BLADDER OF CHILDREN AND ADULTS. PRECAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION. STERILE UNLESS PACKAGE HAS BEEN OPENED OR DAMAGE. WARNING: DO NOT USE PETROLEUM SUBSTRATE LUBRICANTS WITH THE LATEX- BASED URETHRAL CATHETERS SUCH AS PETROLEUM JELLY AND LABEL LIQUID PARAFFIN, WHICH WILL DAMAGE LATEX AND MAY BURST BALLOON. WATER-SOLUBLE LUBRICANT CAN BE USED. STORAGE: CATHETERS NEED TO BE STORED AT ROOM TEMPERATURE AND KEEP AWAY FROM THE DIRECT LIGHT AND PREFERABLY STORED IN THE ORIGINAL PACKING BOX." CORRECTION: D, 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.
IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSURETHRAL ELECTROTOMY OF BLADDER TUMOR UNDER SUBARACHNOID ANESTHESIA TODAY. DURING THE OPERATION, A SINGLE-USE 18-GAUGE TRIPLE-LUMEN (30 ML BALLOON) FOLEY CATHETER MANUFACTURED BY BARD HEALTHCARE SCIENCE (MALAYSIA) CO. LTD. WAS INDWELLED IN THIS PATIENT. THE PATIENT WAS SENT BACK TO THE WARD AT 11:10 AFTER PROCEDURE COMPLETION. AT 16:20 PM, AFTER INSTILLATION OF 20 ML OF 5% GLUCOSE AND 40 MG OF ZORUBICIN HYDROCHLORIDE IN THE BLADDER, THE URINARY CATHETER WAS CLAMPED FOR 30 MINUTES. DURING WARD ROUNDS BY NURSE AT 16:40, IT WAS FOUND THAT THE URINARY CATHETER FELL OUT OF THE PATIENT, AND ABOUT 50 ML OF PINK FLUID WAS DISCHARGED SPONTANEOUSLY. A CAREFUL EXAMINATION INDICATED THAT THE BALLOON OF THE URINARY CATHETER WAS RUPTURED. THE PATIENT DID NOT COMPLAIN ABOUT ANY DISCOMFORT. AT 16:50, NURSE INTENDED TO PLACE A NEW SINGLE-USE 18-GAUGE TRIPLE-LUMEN (30 ML BALLOON) FOLEY CATHETER MANUFACTURED BY BARD HEALTHCARE SCIENCE (MALAYSIA) CO. LTD. IN THE PATIENT ON THE ORDER OF DOCTOR. DURING ROUTINE INSPECTION PRIOR TO PLACEMENT, THE NURSE FOUND THAT THE SALINE INJECTED IN THE BALLOON OF THE URINARY CATHETER COULD NOT BE ASPIRATED COMPLETELY. THE NURSE REPLACED THE URINARY CATHETER WITH A NEW ONE, WHICH WAS PLACED IN THE PATIENT SUCCESSFULLY.
IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSURETHRAL ELECTROTOMY OF BLADDER TUMOR UNDER SUBARACHNOID ANESTHESIA TODAY. DURING THE OPERATION, A SINGLE-USE 18-GAUGE TRIPLE-LUMEN (30 ML BALLOON) FOLEY CATHETER MANUFACTURED BY BARD HEALTHCARE SCIENCE (MALAYSIA) CO. LTD. WAS INDWELLED IN THIS PATIENT. THE PATIENT WAS SENT BACK TO THE WARD AT 11:10 AFTER PROCEDURE COMPLETION. AT 16:20 PM, AFTER INSTILLATION OF 20 ML OF 5% GLUCOSE AND 40 MG OF ZORUBICIN HYDROCHLORIDE IN THE BLADDER, THE URINARY CATHETER WAS CLAMPED FOR 30 MINUTES. DURING WARD ROUNDS BY NURSE AT 16:40, IT WAS FOUND THAT THE URINARY CATHETER FELL OUT OF THE PATIENT, AND ABOUT 50 ML OF PINK FLUID WAS DISCHARGED SPONTANEOUSLY. A CAREFUL EXAMINATION INDICATED THAT THE BALLOON OF THE URINARY CATHETER WAS RUPTURED. THE PATIENT DID NOT COMPLAIN ABOUT ANY DISCOMFORT. AT 16:50, NURSE INTENDED TO PLACE A NEW SINGLE-USE 18-GAUGE TRIPLE-LUMEN (30 ML BALLOON) FOLEY CATHETER MANUFACTURED BY BARD HEALTHCARE SCIENCE (MALAYSIA) CO. LTD. IN THE PATIENT ON THE ORDER OF DOCTOR. DURING ROUTINE INSPECTION PRIOR TO PLACEMENT, THE NURSE FOUND THAT THE SALINE INJECTED IN THE BALLOON OF THE URINARY CATHETER COULD NOT BE ASPIRATED COMPLETELY. THE NURSE REPLACED THE URINARY CATHETER WITH A NEW ONE, WHICH WAS PLACED IN THE PATIENT SUCCESSFULLY.
IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSURETHRAL RESECTION OF BLADDER TUMOR UNDER SUBARACHNOID ANESTHESIA, ANTICIPATED TREATMENT DISEASE OR EFFECT OF BLADDER TUMOR RESECTION ADVERSE EVENT OCCURRED PLACE. THE PATIENT WAS GIVEN WITH 5% GLUCOSE 20ML BIRUBICIN HYDROCHLORIDE 40MG INCIDENTS OF URINARY CATHETER CLAMPING AFTER BLADDER PERFUSION. ALSO THE PATIENT UNDERWENT TRANSURETHRAL SURGERY UNDER SUBARACHNOID ANESTHESIA TODAY FOR BLADDER TUMOR RESECTION. DURING THE OPERATION, A DISPOSABLE NO. 18 THREE-CHAMBER (30ML WATER BLADDER) CATHETER WAS PLACED IN THE PATIENT. THE PATIENT RETURNED TO THE WARD AFTER THE OPERATION AT 11:10 , AND WAS GIVEN 5% AT 16:20 IN THE AFTERNOON. GLUCOSE 20ML BIRUBICIN HYDROCHLORIDE 40MG INTRAVESICAL PERFUSION AND THEN CLAMP THE URINARY CATHETER FOR 30 MINUTES. AT 16:40 THE NURSE INSPECTED THE WARD AND FOUND THAT THE PATIENT'S URINARY CATHETER HAD PROLAPSED AND ABOUT 50ML OF PINK LIQUID WAS DISCHARGED BY ITSELF . CHECK CAREFULLY, THE URINARY CATHETER WATER SAC RUPTURED THE PATIENT HAD NO COMPLAINTS OF DISCOMFORT . AT 16:50 , NURSE FOLLOWED THE DOCTOR'S ADVICE TO RE-INDWELL THE DISPOSABLE NO. 18 THREE-CHAMBER (30ML WATER BAG) URINARY CATHETER PRODUCED BY BARD MEDICAL TECHNOLOGY (MALAYSIA) CO. LTD. AND ROUTINELY CHECKED THE CATHETER WATER BAG BEFORE INDWELLING, AND FOUND WATER AFTER THE SALINE WAS INJECTED INTO THE CAPSULE, IT COULD NOT BE WITHDRAWN COMPLETELY. THE NURSE REPLACED THE URINARY CATHETER WITH A NEW ONE, WHICH WAS PLACED IN THE PATIENT SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2507949 | BARDEX® FOLEY CATHETER SILICONE COATED | FOLEY CATHETER | KOD | C.R. BARD, INC. (COVINGTON) -1018233 | MYEP3445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |