FDA Adverse Event
Malfunction
Summary report: N
HUDSON HCH AQUA+ FILTER
MDR report key: 1922107
·
Received November 18, 2010
Report
- Report Number
- 8040412-2010-00092
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- July 27, 2010
- Report Date
- November 3, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CONNECTING PART OF THE FILTER CRACKED AFTER IT WAS CONNECTED TO THE ENDOTRACHEAL TUBE. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON HCH AQUA+ FILTER | HCH FILTER | CAH | TELEFLEX MEDICAL | NA | 200931 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |