FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE EXTENSION SET
MDR report key: 1935080
·
Received December 6, 2010
Report
- Report Number
- 9616066-2010-00253
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- August 25, 2010
- Report Date
- August 30, 2010
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K061285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE INVOLVED IN THIS EVENT WAS NOT RETURNED. NO FAILURE INVESTIGATION COULD BE PERFORMED.
Description of Event or Problem · 1
THE USER REPORTED THAT THE FEMALE LUER CONNECTION OF THE SET LOOKED MISSHAPEN AND THEY WERE UNABLE TO GET A SECURE CONNECTION WITH A SMARTSITE VALVE, WHICH RESULTED IN A LEAK OF NORMAL SALINE. FROM THE REPORTED INFO, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. NO FURTHER INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMARTSITE EXTENSION SET | FPA | CAREFUSION CORP | 20041E | 10036345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | 2000E (SMARTSITE NEEDLE-FREE VALVE) |