FDA Adverse Event
Malfunction
Summary report: N
GRASEBY MS26 SYRINGE DRIVER
MDR report key: 1841320
·
Received September 16, 2010
Report
- Report Number
- 2183502-2010-00394
- Event Type
- Malfunction
- Date Received
- September 16, 2010
- Report Date
- September 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 RECEIVED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
PER THE REPORTER, THE PATIENT WAS SET TO RECEIVE A 46MM INFUSION OF OVER 24 HOURS. THE INFUSION WAS INITIATED AND CHECKED AFTER 3 HOURS. AT THAT TIME, IT WAS NOTED THE 15MM HAD BEEN INFUSED. THE PATIENT REPORTED NO ILL EFFECTS.
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 |