FDA Adverse Event
Malfunction
Summary report: N
RUSCH CARLENS EB TUBE WITH CARINA HOOK
MDR report key: 3013076
·
Received March 15, 2013
Report
- Report Number
- 8040412-2013-00059
- Event Type
- Malfunction
- Date Received
- March 15, 2013
- Date of Event
- February 27, 2013
- Report Date
- March 1, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CONNECTOR ON THE ENDOBRONCHIAL TUBE BROKE WITHOUT ANY FORCE OR ANY MANIPULATION. NO PRE-TEST WAS CARRIED OUT. NO INTERVENTION REPORTED. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110696 | RUSCH CARLENS EB TUBE WITH CARINA HOOK | ENDOBRONCHIAL TUBE | BTS | TELEFLEX MEDICAL | 12BE07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |