FDA Adverse Event
Malfunction
Summary report: N
CRITICATH
MDR report key: 1052843
·
Received May 27, 2008
Report
- Report Number
- 8020616-2008-00023
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- May 8, 2008
- Report Date
- May 9, 2008
- Manufacturer
- BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
- Product Code
- DYG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED ON 20 MAY 2008. ADD'L INFO HAS BEEN REQUESTED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4). (B) (4).
Description of Event or Problem · 1
THE THERMISTOR CABLE BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRITICATH | THERMODILUTION CATHETER | DYG | BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. | SP5107 | 801195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |