FDA Adverse Event
Malfunction
Summary report: N
TFX ISIS SUBCLOTTIC SEC. ET TUBE, 7.5MM
MDR report key: 2093522
·
Received April 6, 2011
Report
- Report Number
- 3003898360-2011-00134
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 14, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE ET TUBE KINKED AT THE 19CM MARK. THE ALLEGED INCIDENT OCCURRED DURING INTUBATION ON A PATIENT. ANOTHER TUBE WAS USED AND THE PATIENT WAS SUCCESSFULLY INTUBATED. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TFX ISIS SUBCLOTTIC SEC. ET TUBE, 7.5MM | ENDOTRACHEAL TUBE | BTR | TELEFLEX MEDICAL | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |