FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN CBC PRODUCT
MDR report key: 2956459
·
Received January 9, 2013
Report
- Report Number
- 2648666-2013-90008
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- December 5, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER INSTRUMENTS PUERTO RICO
- Product Code
- CAC
- PMA / PMN Number
- K970714
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REASON FOR THE SERIALIZATION STARTING WITH 90008 IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO TRANSFER THE REMAINING COLLECTION OF BLOOD IN THE CANISTER TO THE BLOOD BAG. APPROXIMATELY 200 CC BLOOD WAS DISCARDED. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11339 | UNKNOWN CBC PRODUCT | CAC | STRYKER INSTRUMENTS PUERTO RICO | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |