FDA Adverse Event
Other
Summary report: N
NEOSTAR CENTRAL VENOUS CATHETER
MDR report key: 1215644
·
Received October 20, 2008
Report
- Report Number
- 1056436-2006-00080
- Event Type
- Other
- Date Received
- October 20, 2008
- Date of Event
- October 26, 2006
- Report Date
- October 15, 2008
- Manufacturer
- ANGIODYNAMICS, INC.
- Product Code
- DQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINT WAS CONFIRMED FOR "CUFF TORE OFF." THE CAUSE APPEARS TO BE FROM TISSUE IN-GROWTH OF THE CUFF. WHEN CATHETER WAS REMOVED CUFF REMAINED ATTACHED TO TISSUE. FORCEFUL REMOVAL OF TISSUE ADHERED CATHETER CUFF CAUSED TEARING OF CUFF AND CATHETER CANNULA. A LOT NUMBER WAS NOT PROVIDED, THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. CAUSE OF CUFF TEARING OFF MAY HAVE BEEN RELATED TO PATIENT/PROCEDURAL USER ERROR.
Description of Event or Problem · 1
THE CUFF TORE OFF WHILE THE CATHETER WAS BEING REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEOSTAR CENTRAL VENOUS CATHETER | CHRONIC CVC CATHETER | DQO | ANGIODYNAMICS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |