FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE NEEDLE-FREE VALVE
MDR report key: 2082575
·
Received April 27, 2011
Report
- Report Number
- 9616066-2011-00165
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Report Date
- April 5, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K061285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: 04/27/2011. (B)(4). ALTHOUGH THE DEVICE IS EXPECTED BACK FOR EVAL IT HAS NOT BEEN RECEIVED YET. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RECEIVED AND AN EVAL HAS BEEN PERFORMED.
Description of Event or Problem · 1
VALVE REPORTED TO HAVE CRACKED. UNK IF PRODUCT WAS ON A PT AT THE TIME. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTSITE NEEDLE-FREE VALVE | FPA | CAREFUSION CORPORATION | 2000E | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT, SERIAL# UNK| ALARIS PUMP MODULE, SERIAL# UNK |