FDA Adverse Event
Malfunction
Summary report: N
CVC SET: 16 GA X 16 CM
MDR report key: 2171439
·
Received June 30, 2011
Report
- Report Number
- 9680794-2011-00044
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- May 17, 2011
- Report Date
- June 30, 2011
- Manufacturer
- ARROW INTERNATIONAL INC
- Product Code
- DQO
- PMA / PMN Number
- K820009
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EVENT OCCURRED IN THE SURGERY WARD. THE MEDICATION BEING INFUSED WAS TPN (TOTAL PARENTERAL NUTRITION). THE INSERTION SITE WAS THE RIGHT SUBCLAVIAN VEIN. THE CVC (CENTRAL VENOUS CATHETER) WAS PLACED ON (B)(6) 2011. ON (B)(6) A NURSE FOUND THE CVC IN TWO PIECES. THE LUER CONNECTOR WAS SEPARATED FROM THE EXTENSION LINE. THERE WAS NO HARM TO THE PATIENT AS THE CATHETER WAS STILL CLOSED BY THE CLAMP. THE ANESTHESIOLOGIST WAS CALLED AND THE CVC REMOVED. THERE WERE NO PATIENT INJURIES, COMPLICATIONS OR DEATH REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CVC SET: 16 GA X 16 CM | SINGLE LUMEN CVC PRODUCTS | DQO | ARROW INTERNATIONAL INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | TOTAL PARENTERAL NUTRITION |