FDA Adverse Event
Summary report: N
UNICEL DXI WASH BUFFER II
MDR report key: 2060438
·
Received April 17, 2011
Report
- Report Number
- 2122870-2011-01020
- Date Received
- April 17, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 17, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION WAS PROVIDED. NO ROOT CAUSE WAS DETERMINED FOR THE LEAKING WITH THE INFORMATION SUPPLIED.
Description of Event or Problem · 1
A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THEY RECEIVED ONE DXI WASH BUFFER II CUBETAINER THAT LEAKED. THE ONE LEAKING CUBETAINER AFFECTED THE OTHER ELEVEN BOXES OF WASH BUFFER II ON THE PALETTE. NO INJURY HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL DXI WASH BUFFER II | WASH BUFFER II, | JJE | BECKMAN COULTER INC. | N/A | 331766F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |