FDA Adverse Event
Malfunction
Summary report: N
EXACTA-MED DISPENSER
MDR report key: 663590
·
Received January 6, 2006
Report
- Report Number
- MW1037675
- Event Type
- Malfunction
- Date Received
- January 6, 2006
- Report Date
- January 6, 2006
- Manufacturer
- BAXA CORPORATION
- Product Code
- KYX
- Product Problem
- Yes
- Report Source
- Voluntary report
Narratives
Description of Event or Problem · 0
DISCOVERED A DOSE PROBLEM WITH EXACTA-MED DISPENSER ORAL SYRINGES. EXPECTED TO SEE 5 CC OF ORAL DIGOXIN IN A SYRINGE. THERE WAS ONLY 4CC. BEGAN LOOKING AT ALL ORAL SYRINGES IN THIS PACKAGE AND ALL HAD SOME EVAPORATION. OTHER TYPE OF SYRINGE (BD) WAS FINE. FOUND MANY DIFFERENT SYRINGES SO FEEL IT IS NOT TECHNICIAN ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 0 | EXACTA-MED DISPENSER | ORAL SYRINGE | KYX | BAXA CORPORATION | EXACTA-MED ORAL DISPENSERS | 174215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 0 | * |