FDA Adverse Event
Malfunction
Summary report: N
HUDSON NEONATAL HEATED-WIRE CIRCUIT
MDR report key: 3050304
·
Received April 8, 2013
Report
- Report Number
- 3004365956-2013-00114
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 19, 2013
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE COMPLAINT WAS REPORTED AS: THE COMPLAINT ALLEGES THAT THE CIRCUIT DID NOT PASS THE LEAK TEST. THE ALLEGED INCIDENT OCCURRED PRIOR TO PT USE. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142267 | HUDSON NEONATAL HEATED-WIRE CIRCUIT | HEATED WIRE CIRCUIT | CAI | TELEFLEX MEDICAL | 02A1303293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |