FDA Adverse Event
Injury
Summary report: N
BIVONA CUSTOM FLEXTEND TTS TRACH TUBE
MDR report key: 3843581
·
Received May 21, 2014
Report
- Report Number
- 2183502-2014-00316
- Event Type
- Injury
- Date Received
- May 21, 2014
- Report Date
- May 20, 2014
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- JOH
- PMA / PMN Number
- K923878
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
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
A REPORT WAS RECEIVED STATING THAT THE DEVICE WAS FOUND LEAKING AT THE INFLATION LINE AFTER 17 DAYS IN SITU. THE TRACHEOSTOMY TUBE WAS REPLACED, EMERGENTLY. NO ADVERSE EFFECTS TO PT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303620 | BIVONA CUSTOM FLEXTEND TTS TRACH TUBE | TRACHEOSTOMY TUBE | JOH | SMITHS MEDICAL MD, INC. | NA | CS009699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |