FDA Adverse Event
Malfunction
Summary report: N
STRYKER CBC II DRAIN
MDR report key: 726655
·
Received June 7, 2006
Report
- Report Number
- MW1039524
- Event Type
- Malfunction
- Date Received
- June 7, 2006
- Date of Event
- May 2, 2006
- Report Date
- June 7, 2006
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- CAC
- Product Problem
- Yes
- Report Source
- Voluntary report
Narratives
Description of Event or Problem · 1
FAULTY DRAIN - AFTER 220 ML BLOOD COLLECTED COULD NOT RELEASE BLOOD TO REINFUSION BAG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER CBC II DRAIN | BLOOD CONSERVATION DRAIN | CAC | STRYKER INSTRUMENTS | 225-28-104REV-A | 3080101060320129Q |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |