FDA Adverse Event
Injury
Summary report: N
CVC KIT: 3-LUMEN 7 FR X 20 CM
MDR report key: 3131155
·
Received October 24, 2006
Report
- Report Number
- 1036844-2006-00079
- Event Type
- Injury
- Date Received
- October 24, 2006
- Date of Event
- September 2, 2006
- Report Date
- October 23, 2006
- Manufacturer
- ARROW INTERNATIONAL, INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED WHEN EVAL IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE PT UNDERWENT A LEFT INTERNAL JUGULAR APPROACH. UPON INSERTION, THE SPRING WIRE GUIDE "FRAYED" DURING THE PROCEDURE AND A 2.5CM PIECE OF THE WIRE WAS LEFT IN SOFT TISSUE OF THE LEFT NECK. THE PT WAS TAKEN TO THE OPERATING ROOM. USING FLUOROSCOPY, A CUT DOWN WAS PERFORMED TO REMOVE THE PORTION OF THE WIRE. USING A DIFFERENT INSERTION SITE ANOTHER MULTI LUMEN CATHETER WAS PLACED FOR TEMPORARY INFUSION USE. U/F - (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC KIT: 3-LUMEN 7 FR X 20 CM | ADULT MULTI-LUMEN CATHETER PRODUCTS | DQY | ARROW INTERNATIONAL, INC. | NA | RF0609027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |