FDA Adverse Event
Malfunction
Summary report: N
LS PLUMSET-OL DUAL W/CLAVE & 0.2MICRON FILTER
MDR report key: 1151004
·
Received August 28, 2008
Report
- Report Number
- 9615050-2008-00243
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 5, 2008
- Manufacturer
- HOSPIRA DE COSTA RICA LTD.
- Product Code
- FPA
- PMA / PMN Number
- K953584
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED UNRESTRICTED FLOW. IT WAS REPORTED THAT PRIOR TO PATIENT USE AFTER PRIMING THE TUBING SET WITH NORMAL SALINE, "THE SET KEEPS DRIPPING AFTER PUSHING IN THE FLOW REGULATOR" ON THE CASSETTE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LS PLUMSET-OL DUAL W/CLAVE & 0.2MICRON FILTER | 80-FPA | FPA | HOSPIRA DE COSTA RICA LTD. | NA | 430925H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |