N
Patient 1
MAUDE MDR 5920472
- MDR report key
- 5920472
- Report number
- 5920472
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-07-24
- Date received
- 2016-09-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LUBRI-SIL | CATHETER, RETENTION TYPE, BALLOON | C.R. BARD, INC. | EZK | 903216 | NGAT0207 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-01 | 0 | 1. O |
Event Narratives#
D
Patient 1
AN ELDERLY FEMALE WAS ADMITTED FROM ED TO A MEDICAL BED. A URINARY CATHETER WAS PLACED A FEW DAYS AFTER ADMISSION. AFTER THE CATHETER WAS PLACED, SHE DEVELOPED INCREASING OXYGEN NEEDS AND WAS TRANSFERRED TO THE ICU AFTER RECEIVING SEVERAL DOSES OF LASIX. HER URINE OUTPUT WAS NOTED TO BE DECREASED ONCE IN ICU. NURSING NOTED THE CATHETER TO BE OUT OF THE PATIENT BODY WITH BALLOON INTACT, INFLATED AT 7CC. THESE CATHETERS ARE REPLACEMENTS AT OUR FACILITY WHILE OUR STANDARD URINARY CATHETER IS BACKORDERED. A NEW CATHETER WAS INSERTED. OTHER SUCH INCIDENTS HAVE BEEN REPORTED ANECDOTALLY. I 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.