FDA Adverse Event
Malfunction
Summary report: N
PORTEX TRACHEAL TUBE
MDR report key: 3881237
·
Received February 14, 2014
Report
- Report Number
- 2183502-2014-00031
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 14, 2014
- Report Date
- February 13, 2014
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD
- Product Code
- BTR
- PMA / PMN Number
- K083119
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
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
ACCORDING TO USER FACILITY, DEVICE WAS IN USE WITH PATIENT FOR STOMATOLOGICAL SURGERY. USER FACILITY REPORTED TUBE BECAME KINKED AT OROPHARYNX. NO ADVERSE EFFECTS TO PATIENT REPORTED. REQUESTED ADDITIONAL INFORMATION FROM USER FACILITY; NO RESPONSE RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97987 | PORTEX TRACHEAL TUBE | BTR - TRACHEAL TUBES | BTR | SMITHS MEDICAL INTERNATIONAL LTD | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |