FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 3-LUMEN 12FR X 16CM
MDR report key: 3063720
·
Received April 12, 2013
Report
- Report Number
- 3006425876-2013-00049
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- March 14, 2013
- Report Date
- April 10, 2013
- Manufacturer
- ARROW INTERNATIONAL, INC.
- Product Code
- FOZ
- PMA / PMN Number
- K970864
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN THE EMERGENCY ROOM WHEN REMOVING THE SWG AFTER THE CATHETER INSERTION IN THE INTERNAL JUGULAR VEIN, THE SWG STRETCHED APPROX 10CM FROM THE DISTAL TIP. THE SWG WAS REMOVED HOWEVER THE CATHETER REMAINED IN PLACE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157700 | CVC SET: 3-LUMEN 12FR X 16CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | FOZ | ARROW INTERNATIONAL, INC. | ZF2065042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |