FDA Adverse Event
Injury
Summary report: N
PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE
MDR report key: 2012551
·
Received February 28, 2011
Report
- Report Number
- 2183502-2011-00053
- Event Type
- Injury
- Date Received
- February 28, 2011
- Date of Event
- January 28, 2011
- Report Date
- February 25, 2011
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD
- Product Code
- BTR
- PMA / PMN Number
- K081086
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT AFTER 24 HOURS OF USE THE VENTILATION OF PT BECAME DIFFICULT. ACCORDING TO REPORT, INSPECTION OF THE PRODUCT IN USE SHOWED KINKING AT THE 18CM MARKING. ACCORDING TO REPORT THE TUBING WAS ADJUSTED AND PT WAS LATER REINTUBATED. NO PERMANENT ADVERSE EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE | BTR - TRACHEAL TUBES | BTR | SMITHS MEDICAL INTERNATIONAL LTD | NA | 1388380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |