FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON DRUG CAL II
MDR report key: 2061177
·
Received April 18, 2011
Report
- Report Number
- 2050012-2011-00917
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Date of Event
- March 19, 2011
- Report Date
- March 19, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- DLJ
- PMA / PMN Number
- K993473
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER WAS SENT REPLACEMENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT THEY HAVE A BOX OF SYNCHRON DRUG CAL II WITH THE CAP LOOSE ON L4. THE CONTENTS OF THAT BOTTLE HAVE LEAKED OUT. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT. NO INJURY WAS REPORTED ON THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON DRUG CAL II | SYNCHRON DRUG CAL II | DLJ | BECKMAN COULTER INC. | NA | M002700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |