FDA Adverse Event
Malfunction
Summary report: Y
SYRINGE 150 UL
MDR report key: 8286387
·
Received January 29, 2019
Report
- Report Number
- 1823260-2019-90078
- Event Type
- Malfunction
- Date Received
- January 29, 2019
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JRC
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION CONFIRMED THE CUSTOMER'S ALLEGATION. CUSTOMERS HAVE BEEN INFORMED VIA CUSTOMER NOTIFICATION. THE US IS NOT IMPACTED. THE AFFECTED PART IS USED ONLY ON THE H232 WHICH IS A DEVICE NOT MARKETED IN THE US.
Additional Manufacturer Narrative · 1
THE INVESTIGATION IS ONGOING. THE FOLLOW UP/CORRECTIVE ACTIONS ARE TO BE DETERMINED. THE REPORTED EVENT INVOLVED AN AUTOMATED ANALYTICAL DEVICE WHICH IS SERVICED IN THE FIELD AND NOT ROUTINELY RETURNED FOR INVESTIGATION. THIS DEVICE IS LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.
Description of Event or Problem · 1
THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. A NEEDLE SEPARATED FROM THE SYRINGE BODY OF A ROCHE CARDIAC PIPETTE. NO PATIENTS WERE INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79227 | SYRINGE 150 UL | MICRO PIPETTE | JRC | ROCHE DIAGNOSTICS | SYRINGE 150 UL | 10013153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |