FDA Adverse Event
Death
Summary report: N
ARROW MULTI-LUMEN CVC/ARROWGARD
MDR report key: 509400
·
Received January 30, 2004
Report
- Report Number
- 1036844-2004-00002
- Event Type
- Death
- Date Received
- January 30, 2004
- Date of Event
- November 14, 2003
- Report Date
- January 26, 2004
- Manufacturer
- ARROW INTERNATIONAL, INC.
- Product Code
- DQO
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT WAS RPEORTED THAT THE TRIPLE LUMEN CATHETER WAS PLACED IN THE LEFT INTERNAL JUGULAR FOR TPN ADMINISTRATION. THE PT HAD BEEN DIAGNOSED WITH ULCERATIVE COLITIS. IN 2003, THE PT WAS FOUND UNRESPONSIVE IN THE BATHROOM. DURING A FULL CODE RESUSCITATION, IT WAS NOTICED THAT THE EXTENSION LINE OF THE CATHETER HAD BEEN SEVERED. THE LINE HAD BEEN INTACT WHEN THE PT ENTERED THE BATHROOM. THE PT DIED 4 DAYS LATER OF "A PRESUMED AIR EMBOLUS." THE HOSP CLINICIAN STATED THAT THE PT SEVERED THE CATHETER EXTENSION LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARROW MULTI-LUMEN CVC/ARROWGARD | CENTRAL VENOUS CATHETER KIT | DQO | ARROW INTERNATIONAL, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Death |