FDA Adverse Event
Other
Summary report: N
NEOTREND-L SENSOR
MDR report key: 478415
·
Received August 11, 2003
Report
- Report Number
- 9612233-2003-00014
- Event Type
- Other
- Date Received
- August 11, 2003
- Date of Event
- July 1, 2003
- Report Date
- July 9, 2003
- Manufacturer
- DIAMETRICS MEDICAL, LTD.
- Product Code
- CCE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
THE USER ATTEMPTED TO INSERT THE NEOTREND-L SENSOR INTO AN ARGYLE 5-0 FR UAC. THE SENSOR WENT ABOUT 3-4 CM AND THEN MET RESISTANCE. THE SENSOR WAS RETRACTED IN ORDER TO RE-ATTEMPT INSERTION AND BLOOD LEAKED BACK INTO THE NEOTREND-L SENSOR. NO REPORT OF HARM OR INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEOTREND-L SENSOR | BLOOD GAS MONITORING SYSTEM | CCE | DIAMETRICS MEDICAL, LTD. | N7004L | 872 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |