D
Patient 1
THE CATHETER FELL OUT AND HAD TO BE REPLACED.
MAUDE MDR 3674336
- MDR report key
- 3674336
- Report number
- 1417592-2014-00026
- Event key
- 0
- Event type
- 3
- Date received
- 2014-03-07
- 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 | FOLEY CATHETER, 6FR, SILICONE | MEDLINE INDUSTRIES, INC. | NWR | DYND160806 | 120B0239 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-03-07 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE CATHETER FELL OUT AND HAD TO BE REPLACED. THERE WAS NO PATIENT INJURY OR NEED FOR ADDITIONAL MEDICAL INTERVENTION. THE CATHETER WAS RETURNED AND THE BALLOON WAS FOUND TO BE RUPTURED. A ROOT CAUSE FOR THE RUPTURE IS NOT KNOWN. THE CONTACT AT THE FACILITY HAD VERY LITTLE INFORMATION PERTAINING TO THE INCIDENT AND STATED SHE COULD NOT FURNISH ANY OTHER DETAILS. THE AGE AND SEX OF THE PATIENT AS WELL AS THE DATE OF THE INCIDENT WAS NOT REPORTED. WE DO NOT KNOW HOW MUCH FLUID WAS USED TO INFLATE THE 1.5 ML BALLOON. IT IS NOT KNOWN IF USER ERROR MAY HAVE PLAYED A ROLE IN THE BALLOON RUPTURE. DUE TO THE NEED FOR A NEW CATHETER TO BE INSERTED, THIS MEDWATCH IS BEING FILED.