FDA Adverse Event
Injury
Summary report: N
UNIFUSE INFUSION CATHETER
MDR report key: 2211328
·
Received August 10, 2011
Report
- Report Number
- 2211328
- Event Type
- Injury
- Date Received
- August 10, 2011
- Date of Event
- June 24, 2011
- Report Date
- August 5, 2011
- Manufacturer
- ANGIO DYNAMICS
- Product Code
- KRA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
INFUSION CATHETER USED TO INFUSE THROMBOLYTIC FOR LIMB SALVAGE PROCEDURE; CATHETER WAS FOUND DISLODGED FROM TARGETED SITE WITH LOOP OF CATHER OUT BY 28 CM; SAFETY ISSUE #1 - NO MARKERS ON CATHETER TO HELP HEALTHCARE PROVIDER DETERMINE HOW MUCH THE CATHETER HAD BEEN DISLODGED; SAFETY ISSUE #2 - UNABLE TO SUTURE OF AFFIX CATHETER SO THAT IT REMAINS IN PLACE FOR INFUSION THERAPY. ROOT CAUSE ANALYSIS CONDUCTED; FELT THIS EVENT WAS NOT ABSOLUTE CAUSE OF NEED FOR BELOW-ELBOW AMPUTATION; ACTION ITEM FROM (B)(6) - TO NOTIFY MANUFACTURER OF OUR SAFETY CONCERNS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIFUSE INFUSION CATHETER | INFUSION CATHETER | KRA | ANGIO DYNAMICS | 5 F X 135 CM X 20 CM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other| S |