FDA Adverse Event
Malfunction
Summary report: N
4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KI
MDR report key: 2151241
·
Received June 21, 2011
Report
- Report Number
- 3006260740-2011-00190
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- November 16, 2010
- Report Date
- June 14, 2011
- Manufacturer
- C.R. BARD, INC. (BASD)
- Product Code
- LJS
- PMA / PMN Number
- K034020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF RETA0735 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. ((B)(4)).
Description of Event or Problem · 1
"A LEAKING PICC WAS INVESTIGATED AND PICC FOUND TO STILL HAVE STYLET INSIDE CATHETER. BEND IN CATHETER AND STYLET HAD CAUSED CRACK OR LEAK AT HUB OF STYLET. IV FLUIDS WERE CONNECTED TO LURE ON STYLET WHICH HAD NOT BEEN REMOVED. CONNECTOR FOR FLUID DELIVERY WAS MISSING FROM SET-UP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KI | LJS | C.R. BARD, INC. (BASD) | RETA0735 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |