FDA Adverse Event
Malfunction
Summary report: N
HUDSON TRACH-VENT+HME
MDR report key: 2854415
·
Received November 29, 2012
Report
- Report Number
- 8040412-2012-00190
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- November 1, 2012
- Report Date
- November 9, 2012
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE PT NOTICED THAT HE COULDN'T CONNECT HIS OXYGEN TUBE TO THE TIP OF THE TRACH VENT BECAUSE THIS ONE IS SMALLER THAN USUAL. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON TRACH-VENT+HME | TRACH-VENT HME FILTER | CAH | TELEFLEX MEDICAL | 201149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | OXYGEN TUBE (NOT A TELEFLEX PRODUCT - PER REPORT) |