FDA Adverse Event
Injury
Summary report: N
CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY
MDR report key: 4223722
·
Received October 29, 2014
Report
- Report Number
- 1820334-2014-00567
- Event Type
- Injury
- Date Received
- October 29, 2014
- Report Date
- October 10, 2014
- Manufacturer
- COOK, INC.
- Product Code
- JOH
- PMA / PMN Number
- K133597
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
THE RIDGE ON THE LONG WHITE CATHETER WAS INCOMPLETE AND ALLOWED THE BLUE RHINO TO GO THRU THE END OF THE CATHETER. THE NEEDLE HOLDER'S JAW WOULD NOT LOCK DURING THE PROCEDURE. THIS EVENT RESULTED IN A SCRATCH TO THE PT'S CARINA. THE SURGEON WAS ABLE TO CONTROL THE BLEEDING. THE BLEEDING WAS CONTROLLED BY THE SURGEON INTRAOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 691280 | CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY | JOH | COOK, INC. | NA | 4813936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |