FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 1001378
·
Received February 20, 2008
Report
- Report Number
- 2090040-2008-00001
- Event Type
- Malfunction
- Date Received
- February 20, 2008
- Date of Event
- January 18, 2008
- Report Date
- February 20, 2008
- Manufacturer
- ASCENT HEALTHCARE SOLUTIONS
- Product Code
- DQO
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE WAS RESTERILIZED THROUGH OUR OPEN/UNUSED PROCESS. THE COMPLETION OF THIS REPORT IS ON HOLD PENDING A FAILURE MODE ANALYSIS REPORT FROM A THIRD PARTY LAB.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE CATHETER BROKE OFF IN THE PT'S LEG. THE TIP WAS RETRIEVED WITH NO FURTHER INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NA | RESTERILIZED MICRO PATENCY CATHETER | DQO | ASCENT HEALTHCARE SOLUTIONS | 41069-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |