FDA Adverse Event
Malfunction
Summary report: N
HUDSON NUP-DRAFT II OPTI-NEB NEUBILIZER W/RES
MDR report key: 2359857
·
Received November 8, 2011
Report
- Report Number
- 3004365956-2011-00481
- Event Type
- Malfunction
- Date Received
- November 8, 2011
- Date of Event
- October 31, 2011
- Report Date
- November 2, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
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 THE OPTINEB LEAKS AROUND THE THREADS THAT CLOSE THE CAP. THE ALLEGED ISSUE CAUSED A TIDAL VOLUME ALARM ON THE VENTILATOR. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON NUP-DRAFT II OPTI-NEB NEUBILIZER W/RES | NEBULIZER | CAF | TELEFLEX MEDICAL | 02G1102061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |