FDA Adverse Event
Injury
Summary report: N
BCS(R) XP SYSTEM
MDR report key: 2002638
·
Received February 28, 2011
Report
- Report Number
- 9610806-2011-00001
- Event Type
- Injury
- Date Received
- February 28, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 7, 2011
- Manufacturer
- SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
- Product Code
- GJS
- PMA / PMN Number
- K003870
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE OF THE BROKEN VIAL IS UNKNOWN. NO FURTHER EVALUATION OF THE DEVICE IS POSSIBLE.
Description of Event or Problem · 1
AN OPERATOR WAS PERFORMING STANDARD OPERATIONS WITH THE THROMBOREL S REAGENT VIAL AND A FINGER WAS CUT BY THE GLASS VIAL. THE BOTTOM OF THE VIAL BROKE DURING OPENING. THE OPERATOR RECEIVED MEDICAL ATTENTION IMMEDIATELY AND EVERY TWO DAYS FOR SPECIAL WOUND TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BCS(R) XP SYSTEM | THROMBOREL S | GJS | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |