FDA Adverse Event
Malfunction
Summary report: N
HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT
MDR report key: 1842158
·
Received August 31, 2010
Report
- Report Number
- 3004365956-2010-00251
- Event Type
- Malfunction
- Date Received
- August 31, 2010
- Date of Event
- August 23, 2010
- Report Date
- August 23, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS RETURNED FOR EVAL, HOWEVER, THE RESULTS OF THE EVAL ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: DURING THE PRE-USE TEST, THE CIRCUITS WERE NOTED AS LEAKING. THE CUSTOMER REPORTS THAT THE DROP LINES WERE NOT STAYING CONNECTED. THE CONNECTOR PIECE WAS TOO LOOSE TO HOLD THE CORRUGATED TUBING. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT | VENTILATOR CIRCUIT | CAI | TELEFLEX MEDICAL | NA | 02F1002756 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |