FDA Adverse Event
Malfunction
Summary report: N
GEMINI ADMINISTRATION SET
MDR report key: 1397572
·
Received March 31, 2009
Report
- Report Number
- 9616066-2009-00184
- Event Type
- Malfunction
- Date Received
- March 31, 2009
- Date of Event
- March 5, 2009
- Report Date
- March 6, 2009
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- FPA
- PMA / PMN Number
- K931173
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4).
Description of Event or Problem · 1
USER REPORTED A LEAKAGE DURING AN INFUSION OF GLUCOSE. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. THE IV ADMINISTRATION SET HAS BEEN REQUESTED FOR INVESTIGATION BUT NOT YET RECEIVED TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEMINI ADMINISTRATION SET | FPA | CARDINAL HEALTH ALARIS PRODUCTS | 2200-0006 | 08095819 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |