FDA Adverse Event
Malfunction
Summary report: N
GRASEBY MS26 SYRINGE DRIVER
MDR report key: 1901583
·
Received November 10, 2010
Report
- Report Number
- 2183502-2010-00533
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 13, 2010
- Report Date
- November 8, 2010
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- FRN
- PMA / PMN Number
- K830151
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT THE PUMP INFUSED MORE QUICKLY THAN PROGRAMMED. NO FURTHER DETAILS ARE AVAILABLE. NO ADVERSE EFFECTS TO PT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRASEBY MS26 SYRINGE DRIVER | FRN | SMITHS MEDICAL INTERNATIONAL LTD. | MS26 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |