D
Patient 1
AFTER THE CATHETER WAS INSERTED, THE BALLOON WOULD NOT INFLATE. A NEW CATHETER WAS INSERTED.
MAUDE MDR 4194086
- MDR report key
- 4194086
- Report number
- 1417592-2014-00093
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-09-09
- Date received
- 2014-10-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JULIE FINLEY
- Address
- ONE MEDLINE PLACE MUNDELEIN IL 60060 US
- Phone
- 847-847-8476
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LATEX FOLEY CATHETER, 16F | MEDLINE INDUSTRIES, INC. | NWR | DYND160116 | 13CB2526A | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-10-14 | 0 | 1. O |
Event Narratives#
N
Patient 1
DURING A GYNE PROCEDURE, AFTER THE FOLEY CATHETER WAS INSERTED, THE BALLOON WOULD NOT INFLATE AND THE CATHETER WAS REPLACED. THERE WAS NO INJURY TO THE PT. THE FACILITY REPORTED THAT AS THEY ATTEMPTED TO INFLATE THE BALLOON WITH FLUID, THEY VISUALIZED A BALLOON SHAPED PROTRUSION DISTAL TO THE Y-JUNCTION OF THE CATHETER. FLUID WAS ALLOWED TO PASS THROUGH THE INFLATION VALVE AND INTO THE INFLATION LUMEN. WE HAVE NO SAMPLE TO EVALUATE. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED BUT BASED ON THE INFO PROVIDED, IT APPEARS THAT THE INFLATION VALVE FUNCTIONED PROPERLY AND FLOW WAS THEN OBSTRUCTED AT THE BIFURCATION.