BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER
Report
- Report Number
- 1018233-2019-03867
- Event Type
- Malfunction
- Date Received
- July 12, 2019
- Date of Event
- June 19, 2019
- Report Date
- September 20, 2019
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- MJC
- PMA / PMN Number
- K910318
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
THE REPORTED EVENT WAS CONFIRMED AS A MANUFACTURING RELATED ISSUE DUE TO POOR INFLATION COVERAGE THICKNESS, RESULTING IN COLLAPSE LUMEN. A REVIEW OF THE MANUFACTURING PROCESS INDICATES THAT THE PROCESS IS CAPABLE OF PRODUCING OF THIS TYPE OF DEFECT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND A POSSIBLE MANUFACTURING ISSUE(S) THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: [WARNINGS] 1. METHOD FOR USE (1) DO NOT INFLATE THE BALLOON IN THE URETHRA. [THE URETHRA MAY BE INJURED.] (2) DO NOT PULL THE CATHETER HARD. [THE BLADDER/URETHRA MAY BE INJURED.] 2. APPLICABLE PATIENTS (1) PATIENTS WITH DELIRIUM WHO MIGHT PULL OUT CATHETER [WHEN PATIENT TUGS AT CATHETER UNCONSCIOUSLY, THE BLADDER AND URETHRA MAY BE DAMAGED.] "CONTRAINDICATIONS] 1. METHOD FOR USE: (1) DO NOT REUSE. (2) DO NOT RESTERILIZE. (3) BE CAREFUL THAT THE CATHETER IS NOT EXPOSED TO OINTMENTS, CONTRAST MEDIUM OR OIL-BASED LUBRICANTS (INCLUDING VEGETABLE OILS SUCH AS OLIVE OIL, MINERAL OILS SUCH AS WHITE PETROLATUM AND ANIMAL OILS). [THEY MAY DAMAGE THE DEVICE AND MAY BURST BALLOON.] (4) DO NOT HOLD THE DEVICE WITH FORCEPS, ETC. AVOID CONTACT WITH ANY BLADES OR SHARP-EDGED INSTRUMENTS. [CATHETER DAMAGE MAY CAUSE BALLOON RUPTURE AND ACCIDENTAL BALLOON REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON.] 2. APPLICABLE PATIENTS (1) PATIENTS WHO ARE OR HAVE BEEN ALLERGIC TO NATURAL RUBBER LATEX (2) PATIENTS WITH KNOWN ALLERGY TO SILVER COATED CATHETER 2. PRECAUTIONS FOR USE 1) CLEANSE THE AREA AROUND THE EXTERNAL URETHRAL MEATUS WITH THE COTTON BALLS IMMERSED IN THE ANTISEPTICS. 2) LUBRICATE THE DISTAL END OF THE CATHETER WITH WATER-SOLUBLE LUBRICANT. 3) INSERT CATHETER INTO THE URETHRAL MEATUS AND ADVANCE IT UNTIL THE BALLOON ENTERS THE BLADDER AND URINE FLOWS OUT THROUGH THE CATHETER. USING A NEEDLE-LESS SYRINGE, INFUSE THE SPECIFIED VOLUME OF STERILE WATER INTO THE INFLATION LUMEN TO INFLATE THE BALLOON. 4) PULL CATHETER TO SEAT THE BALLOON AT THE LEVEL OF THE BLADDER NECK AND SECURE PLACEMENT. 5) CONNECT LEAD WIRE TO MONITOR THROUGH EXTENSION CABLE. 6) TO DEFLATE BALLOON AND REMOVE CATHETER, INSERT A LUER TIP (NEEDLELESS) SYRINGE IN THE INFLATION VALVE TO ALLOW THE WATER TO DRAIN SPONTANEOUSLY. AFTER BALLOON DEFLATION, WITHDRAW THE CATHETER WHILE CONFIRMING THAT NO RESISTANCE IS ENCOUNTERED. 7) WHEN RESISTANCE IS ENCOUNTERED IN INSERTING CATHETER, STOP THE PROCEDURE AND REMOVE THE CATHETER. 8) WHEN DEFLATING BALLOON, DO NOT ASPIRATE WITH A SYRINGE BY HANDS. [THE INFLATION LUMEN FOR BALLOON DEFLATION MAY BE OCCLUDED BY NEGATIVE PRESSURE, AND AS A RESULT THE CATHETER CANNOT BE REMOVED.]"
IT WAS REPORTED THAT IT WAS DIFFICULT TO DEFLATE THE BALLOON ON THE 2ND DAY OF USE. THE USER NOTED THAT THEY PULLED AND REMOVED THE CATHETER WHILE THE CATHETER WAS STILL SLIGHTLY INFLATED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT IT WAS DIFFICULT TO DEFLATE THE BALLOON ON THE 2ND DAY OF USE. THE USER NOTED THAT THEY PULLED AND REMOVED THE CATHETER WHILE THE CATHETER WAS STILL SLIGHTLY INFLATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 580798 | BARDEX® I.C. TEMPERATURE SENSING FOLEY CATHETER | FOLEY CATHETER (LATEX) | MJC | C.R. BARD, INC. (COVINGTON) -1018233 | 8JD7147 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |