FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE NEEDLE-FREE VALVE
MDR report key: 3945321
·
Received May 7, 2014
Report
- Report Number
- 9616066-2014-00489
- Event Type
- Malfunction
- Date Received
- May 7, 2014
- Report Date
- April 14, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K061285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE MODEL#/CATALOG# IDENTIFIED IN IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT. SAMPLE INVOLVED IN THIS EVENT WILL NOT BE RETURNED AS IT WAS NOT AVAILABLE. NO FAILURE INVESTIGATION COULD BE PERFORMED.
Description of Event or Problem · 1
A CHEMOTHERAPY SYRINGE CONNECTED TO A TEXIUM ((B)(4)) WAS SUPPLIED BY THE PHARMACY. THE CUSTOMER REPORTED THAT APPROXIMATELY 2 MINUTES INTO A CHEMOTHERAPY BOLUS THEY IDENTIFIED A LEAK BETWEEN THE SMARTSITE AND THE TEXIUM . FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274998 | SMARTSITE NEEDLE-FREE VALVE | NONE | FPA | CAREFUSION CORPORATION | 2000E7D | 13086010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | THERAPY DATE UNKNOWN| MODEL 10012241-0500/LOT UNKNOWN,| SYRINGE,| TEXIUM CLOSED MALE LUER| MANUFACTURER/MODEL/LOT UNKNOWN, |