FDA Adverse Event
Malfunction
Summary report: N
SOLUSET 150 X 60 BURETTE SET, LATEX FREE
MDR report key: 1001719
·
Received February 19, 2008
Report
- Report Number
- 9615050-2008-00051
- Event Type
- Malfunction
- Date Received
- February 19, 2008
- Date of Event
- January 1, 2008
- Report Date
- January 22, 2008
- Manufacturer
- HOSPIRA DE COSTA RICA LTD.
- Product Code
- FPK
- PMA / PMN Number
- K941214
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED NO FLOW. THE SOLUSET WAS BEING USED TO DELIVER NORMAL SALINE. THE CUSTOMER CONTACT REPORTED THAT AFTER THE SOLUSET WAS PRIMED, THE SOLUTION WOULD NOT FLOW WHEN THE DELIVERY WAS STARTED. IT WAS REPORTED AFTER THE SOLUSET WAS SHAKEN, FLOW OF FLUID BEGAN. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTION WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLUSET 150 X 60 BURETTE SET, LATEX FREE | 80-FPK | FPK | HOSPIRA DE COSTA RICA LTD. | NA | 460625G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |