D
Patient 1
LUER/CONNECTOR SEPARATED FROM TUBING ON CATHETER.
MAUDE MDR 2049680
- MDR report key
- 2049680
- Report number
- 3006242715-2011-00008
- Event key
- 0
- Event type
- 3
- Date of event
- 2011-03-10
- Date received
- 2011-03-24
- 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
- MARK BLAZEI
- Address
- 7550 MERIDIAN CIRCLE N STE 150 MAPLE GROVE MN 55369 US
- Phone
- 866-866-8669
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DURASPAN DIALYSIS CATHETER 15.5F X 28CM | DIALYSIS CATHETER | R4 VASCULAR | MSD | NA | 62152820 | R402D168P | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-03-24 | 0 |
Event Narratives#
N
Patient 1
THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. ADD'L EVAL OF THE LOT IS IN PROCESS.