D
Patient 1
THE RN WAS UNABLE TO REMOVE APPROX 3ML OF FLUID FROM THE CATHETER'S BALLOON.
MAUDE MDR 4210068
- MDR report key
- 4210068
- Report number
- 1417592-2014-00094
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-06-09
- Date received
- 2014-10-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- 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, 14F | MEDLINE INDUSTRIES, INC. | NWR | DYND160214 | 14CB9965 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-10-15 | 0 | 1. O |
Event Narratives#
N
Patient 1
ONE TO TWO DAYS POST INSERTION, THE RN ATTEMPTED TO REMOVE THE FOLEY CATHETER AND THE BALLOON WOULD NOT FULLY DEFLATE. SHE WAS ABLE TO REMOVE 7ML OF FLUID WITHOUT ISSUE BUT WAS UNABLE TO REMOVE THE REMAINING 2-3ML. THE CATHETER WAS PULLED OUT WITH A PARTIALLY INFLATED BALLOON INTACT. THE FACILITY REPORTED THAT NO SERIOUS INJURY RESULTED AND NO MEDICAL INTERVENTION WAS INITIATED AS A RESULT OF THIS INCIDENT. THE CATHETER WAS NOT REPLACED. THE SAMPLE WAS NOT RETURNED FOR EVAL. A ROOT CAUSE HAS NOT BEEN DETERMINED.