FDA Adverse Event
Malfunction
Summary report: N
BIVONA MICROLARYNGEAL WIRE TUBE
MDR report key: 1623193
·
Received February 23, 2010
Report
- Report Number
- 2183502-2010-00032
- Event Type
- Malfunction
- Date Received
- February 23, 2010
- Date of Event
- January 14, 2010
- Report Date
- February 16, 2010
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- KAC
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.
Description of Event or Problem · 1
ACCORDING TO REPORTER, THEY WERE UNABLE TO VENTILATE POST INTUBATION. THEY VISUALIZED THE INTERIOR OF THE MICROLARYNGEAL TUBE WITH BRONCHOSCOPE. TUBE WAS OCCLUDED AGAINST THE ANTERIOR WALL OF TRACHEA. TUBE REMOVED, PATIENT RECOVERED AFTER TUBE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIVONA MICROLARYNGEAL WIRE TUBE | KAC-TUBE LARYNGECTOMY | KAC | SMITHS MEDICAL ASD, INC. | NA | 1623622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |