BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
Report
- Report Number
- 1018233-2021-08340
- Event Type
- Malfunction
- Date Received
- December 22, 2021
- Date of Event
- December 1, 2021
- Report Date
- March 7, 2022
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZL
- UDI-DI
- 00801741034169
- PMA / PMN Number
- K040504
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿BAD FIT WITH CONNECTOR ¿. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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: "CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER AND MAY CAUSE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. PLEASE CONSULT PRODUCT LABEL AND INSERT FOR ANY INDICATIONS, CONTRAINDICATIONS, HAZARDS, WARNINGS, CAUTIONS AND DIRECTIONS FOR USE. PROPER TECHNIQUES FOR URINARY CATHETER INSERTION ¿ PERFORM HAND HYGIENE IMMEDIATELY BEFORE AND AFTER INSERTION ¿ INSERT URINARY CATHETERS USING ASEPTIC TECHNIQUE AND STERILE EQUIPMENT ¿ USE THE SMALLEST FOLEY CATHETER POSSIBLE, CONSISTENT WITH GOOD DRAINAGE ¿ DOCUMENT THE INDICATIONS FOR CATHETER INSERTION, DATE AND TIME OF CATHETER INSERTION, INDIVIDUAL WHO INSERTED CATHETER, AND DATE AND TIME OF CATHETER REMOVAL IN PATIENT RECORD PROPER TECHNIQUES FOR URINARY CATHETER MAINTENANCE ¿ SECURE THE FOLEY CATHETER, USE THE STATLOCK® FOLEY STABILIZATION DEVICE IF PROVIDED ¿ MAINTAIN A CLOSED DRAINAGE SYSTEM BY UTILIZING PRE-CONNECTED, SEALED CATHETER-TUBING JUNCTIONS ¿ MAINTAIN UNOBSTRUCTED URINE FLOW AND KEEP THE CATHETER AND COLLECTION TUBE FREE FROM KINKING ¿ KEEP THE COLLECTION BAG BELOW THE LEVEL OF THE BLADDER OR HIPS AT ALL TIMES ¿ EMPTY THE COLLECTION BAG REGULARLY (E.G., PRIOR TO TRANSPORT) USING A SEPARATE, CLEAN COLLECTION CONTAINER FOR EACH PATIENT ¿ ROUTINE HYGIENE (E.G., CLEANSING OF THE MEATAL SURFACE DURING DAILY BATHING OR SHOWERING) IS APPROPRIATE ¿ LEAVE FOLEY CATHETER IN PLACE ONLY AS LONG AS NEEDED" H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT THE FOLEY CATHETERS WERE LEAKING.
IT WAS REPORTED THAT THE FOLEY CATHETERS WERE LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1966035 | BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER | FOLEY CATHETER | EZL | C.R. BARD, INC. (COVINGTON) -1018233 | 175816 | NGFW2907 | 00801741034169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |