FDA Adverse Event
Other
Summary report: N
BD DTX PLUS TRANSDUCER WITH PRESSURE MONITORING SET
MDR report key: 1553130
·
Received December 4, 2009
Report
- Report Number
- 8020616-2009-00022
- Event Type
- Other
- Date Received
- December 4, 2009
- Date of Event
- January 1, 2009
- Report Date
- November 17, 2009
- Manufacturer
- BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
- Product Code
- DXN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED FROM THE REPORTER. THE SAMPLE HAS NOT BEEN RECEIVED AT THIS TIME. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE DEVICE BROKE ON THE PORT LINE SIDE THAT INFUSES THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD DTX PLUS TRANSDUCER WITH PRESSURE MONITORING SET | DISPOSABLE PRESSURE TRANSDUCER WITH PRESSURE MONITORING SET | DXN | BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. | DT-4812 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |