FDA Adverse Event
Injury
Summary report: N
SHILEY
MDR report key: 781146
·
Received November 13, 2006
Report
- Report Number
- 2936999-2006-00872
- Event Type
- Injury
- Date Received
- November 13, 2006
- Date of Event
- January 1, 2006
- Report Date
- November 6, 2006
- Manufacturer
- JUAREZ HENEQUEN
- Product Code
- BTO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS COMPLAINT IS CURRENTLY IN PROGRESS. THE SAMPLE ASSOCIATED TO THIS COMPLAINT IS NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
ON 11/06/2006. NELLCOR PURITAN BENNETT RECEIVED A REPORT OF A PILOT LINE DISCONNECTION FROM A TUBE SCT SPECIALIZED TRACHEOSTOMY TUBE. THE CALLER REPORTED TAHT THE PILOT LINE DISCONNECTED FROM THE TRACHEOSTOMY TUBE WHILE IN A PATIENT. THE CALLER REPORTED THAT THE PATIENT HAD TO BE RE-INTUBATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHILEY | SPECIALIZED TRACHEOSTOMY TUBE | BTO | JUAREZ HENEQUEN | SCT | 0605002602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |