LUBRI-SIL
Received Sep 1, 2016 · Event occurred Jul 24, 2012
Report 5920477 · MDR key 5920477
Device
Generic name
Catheter, Retention Type, Balloon
Manufacturer
C.r. Bard, Inc.Catalog number
903216
Lot number
NGAS1472
Product problems
- Inflation Problem
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A PREVIOUSLY PLACED URINARY CATHETER FELL OUT OF A SEDATED MALE PATIENT IN THE ICU. THE CATHETER HAD BEEN INSERTED THE DAY BEFORE IN THE ED WHEN THE PT WAS INTUBATED NASALLY FOR ANGIO-EDEMA. WHEN THE ICU NURSE CHECKED THE CATHETER THAT CAME OUT OF THE PATIENT, SHE FOUND THAT THE BALLOON DID INFLATE. THE NURSE BELIEVES THAT THE BALLOON MUST HAVE BEEN MUST INFLATED BECAUSE THERE WAS SOME WATER IN THE BALLOON WHEN INFLATED WITH AIR. A NEW CATHETER WAS INSERTED. WE USED THIS SUBSTITUTE PRODUCT FOR ABOUT TWO WEEKS. WE HAVE USED ABOUT 20 KITS. THEY WERE STORED IN THE CLEAN SUPPLY ROOM AS WELL AS IN THE STAT-ROOM ON THE SECOND FLOOR. OTHER SUCH INCIDENTS HAVE BEEN REPORTED ANECDOTALLY. WE HAVE NOT BEEN ABLE TO CONFIRM ANY DETAILS OF A 3RD AND POSSIBLY 4TH SUCH EVENT, BUT THIS IS A RECURRING PROBLEM AT OUR FACILITY WITH THESE REPLACEMENT CATHETERS. MANUFACTURER RESPONSE FOR URINARY CATHETER, TRAY FOLEY 16FR W/URIMETER (PER SITE REPORTER): THE COMPANY HAS ASKED FOR ADDITIONAL INFORMATION AND I WILL CONTACT THEM.