FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 3-LUMEN 4FR X 13CM
MDR report key: 3915444
·
Received February 25, 2014
Report
- Report Number
- 3006425876-2014-00037
- Event Type
- Malfunction
- Date Received
- February 25, 2014
- Date of Event
- February 6, 2014
- Report Date
- February 13, 2014
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT INSERTION OF THE CVC INTO THE 2 (B)(6) PT'S SUBCLAVIA WAS A FAILURE. THE USE REPORTED THAT THE CATHETER HAD TO BE REMOVED, AS IT WAS NOT POSSIBLE TO REMOVE THE SWG SEPARATELY. THE USER ALSO REPORTED THAT THE SWG "HOOKED" AT THE CATHETER TIP. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED WITH A NEW CATHETER; HOWEVER THE SECOND ATTEMPT WAS NOT SUCCESSFUL. IT IS UNK WHETHER THERE WAS A DELAY REPORTED, HOWEVER THERE WERE NO COMPLICATIONS OR DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116211 | CVC SET: 3-LUMEN 4FR X 13CM | PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL INC | 71F13K0430 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 DA |