FDA Adverse Event
Malfunction
Summary report: N
PORTEX BLUE LINE UNCUFFED ENDOTRACHEAL TUBE
MDR report key: 1632537
·
Received March 4, 2010
Report
- Report Number
- 2183502-2010-00055
- Event Type
- Malfunction
- Date Received
- March 4, 2010
- Date of Event
- January 27, 2010
- Report Date
- February 25, 2010
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- BTR
- Removal / Correction Number
- 9610530-09/08/09-002-R
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER COMPLETED THE ENTIRE FORM. CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
THE USER ENCOUNTERED DIFFICULTY INSERTING A SUCTION TUBE THROUGH THE ENDOTRACHEAL TUBE WHILE IN SITU. NO LASTING INCIDENT-RELATED MEDICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX BLUE LINE UNCUFFED ENDOTRACHEAL TUBE | BTR - ENDOTRACHEAL TUBE | BTR | SMITHS MEDICAL INTERNATIONAL LTD. | NA | 904089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |