FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® WASH CONCENTRATE II
MDR report key: 2063558
·
Received April 19, 2011
Report
- Report Number
- 2050012-2011-01215
- Event Type
- Malfunction
- Date Received
- April 19, 2011
- Date of Event
- March 21, 2011
- Report Date
- March 21, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K965240
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT AND THE ISSUE WAS RESOLVED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO SYNCHRON WASH CONCENTRATE II BOTTLE THAT LEAKED WHEN LOADED ON THE INSTRUMENT. THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® WASH CONCENTRATE II | GENERAL PURPOSE REAGENT | JJE | BECKMAN COULTER, INC. | NA | T005155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |