FDA Adverse Event
Injury
Summary report: N
CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
MDR report key: 1365260
·
Received April 14, 2009
Report
- Report Number
- 1820334-2009-00175
- Event Type
- Injury
- Date Received
- April 14, 2009
- Date of Event
- March 4, 2009
- Report Date
- March 16, 2009
- Manufacturer
- COOK, INC.
- Product Code
- KCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE PATIENT HAD A PERCUTANEOUS TRACH PLACED AT BEDSIDE. THE NEXT DAY, THE NURSE NOTICED THAT THE PHALANGE WAS BROKEN ON EACH SIDE OF THE TRACH, AND NOTIFIED THE SURGEON AND THE PULMONARY PHYSICIAN. THE SURGEON WAS IN THE PT'S ROOM WITHIN THE HOUR AND REMOVED THE TRACH AND ORALLY INTUBATED THE PT. PT OUTCOME UNKNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET | DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION | KCG | COOK, INC. | 2097024-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |