FDA Adverse Event
Malfunction
Summary report: N
HUDSON ISO-GARD DEPTH FILTER
MDR report key: 3032753
·
Received March 29, 2013
Report
- Report Number
- 8040412-2013-00062
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 18, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS RECEIVED FOR EVALUATION, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE HME FILTER BROKE DURING USE ON A PATIENT. THE CLINICIAN PUT A NEW HME ON THE PATIENT. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 130439 | HUDSON ISO-GARD DEPTH FILTER | HME FILTER | CAH | TELEFLEX MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |