FDA Adverse Event
Malfunction
Summary report: N
HUDSON CANNULA, OVER-THE-EAR NASAL TIP, 7'
MDR report key: 2171426
·
Received June 29, 2011
Report
- Report Number
- 3004365956-2011-00264
- Event Type
- Malfunction
- Date Received
- June 29, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 21, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BZD
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT CANNULA DOES NOT HAVE A HOLE FOR OXYGEN DELIVERY. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON CANNULA, OVER-THE-EAR NASAL TIP, 7' | CANNULA NASAL TIP | BZD | TELEFLEX MEDICAL | NA | 02C1102724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |