FDA Adverse Event
Malfunction
Summary report: N
SOLUSET 150 X 60 BURETTE SET, LATEX FREE
MDR report key: 1001720
·
Received February 19, 2008
Report
- Report Number
- 9615050-2008-00052
- 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
A DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF PARTICULATE. THE CUSTOMER CONTACT REPORTED THAT AFTER SPIKING THE SOURCE CONTAINER AND "PUSHING THE TIP INTO THE RUBBER, FROM TIME TO TIME THERE ARE PIECES THAT GO IN THE SOLUSET." THE SOLUSETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 |