FDA Adverse Event
Malfunction
Summary report: N
FREEDOM 60 SET TUBING
MDR report key: 245969
·
Received October 25, 1999
Report
- Report Number
- MW1017390
- Event Type
- Malfunction
- Date Received
- October 25, 1999
- Date of Event
- October 10, 1999
- Report Date
- October 12, 1999
- Manufacturer
- REPRO-MED SYSTEMS, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
UNABLE TO PRIME TUBING WITH MEDICATION SYRINGE. WHEN ATTEMPT MADE TO FORCE FLUID (MED) THROUGH TUBING THE FORCE CAUSED THE "WRAGS" OF THE MEDICATION SYRINGE RENDERING IT USELESS TO FREEDOM 60 PUMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FREEDOM 60 SET TUBING | FREEDOM 60 TUBING | FPA | REPRO-MED SYSTEMS, INC. | PART# F60ML | H225802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 MO |