D
Patient 1
THE CLINICIAN ATTEMPTED TO REMOVE THE CATHETER FOLLOWING A SURGICAL PROCEDURE. THE BALLOON WOULD NOT DEFLATE.
MAUDE MDR 3621483
- MDR report key
- 3621483
- Report number
- 1417592-2014-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-12-18
- Date received
- 2014-01-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
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 | KATEX FOLEY CATHETER TRAY, 16F | MEDLINE INDUSTRIES, INC. | NWR | DYND160116 | UNK | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-01-30 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE CATHETER WAS INSERTED IN THE OPERATING ROOM PRIOR TO A SURGICAL PROCEDURE. LATER THAT DAY, THE CLINICIAN WAS UNSUCCESSFUL IN DEFLATING THE BALLOON IN ORDER TO REMOVE THE CATHETER. SHE CUT THE PIGTAIL ON THE INFLATION PORT AND OBSERVED SOME DROPS OF FLUID BUT FULL DEFLATION WAS NOT ACHIEVED. THE PHYSICIAN ATTEMPTED TO RUPTURE THE BALLOON BY INSERTING A NEEDLE BUT WAS UNSUCCESSFUL. DURING THE NIGHT, WHEN THE PATIENT GOT UP, THE CATHETER FELL OUT ON ITS OWN. NO ADD'L INTERVENTION WAS NECESSARY. THE CATHETER WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED A DEFLATED BALLOON AND A SEVERED INFLATION VALVE. THE INFLATION VALVE WAS NOT RETURNED TO US. THE CATHETER BALLOON WAS INFLATED THROUGH THE INFLATION LUMEN WITH WATER. THE BALLOON INFLATED AND DEFLATED AS INTENDED. THE REPORTED ISSUE COULD NOT BE DUPLICATED WITH THE RETURNED SAMPLE. A ROOT WAS NOT DETERMINED.