FDA Adverse Event
Injury
Summary report: N
0.8% SELECTOGEN
MDR report key: 1522399
·
Received November 2, 2009
Report
- Report Number
- 2250051-2009-00305
- Event Type
- Injury
- Date Received
- November 2, 2009
- Date of Event
- October 8, 2009
- Report Date
- November 2, 2009
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Product Code
- MWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO SUPERVISOR, THE TECH IMMEDIATELY WASHED THE EYE WITH RUNNING WATER AND FOLLOWED-UP WITH EMPLOYEE HEALTH. TECH HAS RETURNED TO WORK.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT A SMALL AMOUNT OF REAGENT RED CELLS SPLASHED INTO A BLOOD BANK TECH'S EYE WHEN THE TECH WAS DISPENSING RED CELLS BACK INTO THE VIAL. THE TECH WAS WEARING GLASSES, THEREFORE ONLY A SMALL AMOUNT OF RED CELLS SPLASHED INTO THE EYE. OCD'S MEDICAL DIRECTOR HAS CLASSIFIED THIS EVENT AS A SERIOUS INJURY. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 0.8% SELECTOGEN | REAGENT RED BLOOD CELLS | MWN | ORTHO-CLINICAL DIAGNOSTICS | NA | VS301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |