FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE NEEDLE-FREE VALVE
MDR report key: 3033360
·
Received March 1, 2013
Report
- Report Number
- 9616066-2013-00122
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- January 29, 2013
- Report Date
- February 5, 2013
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K061285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE MODEL #/CATALOG # IDENTIFIED IN SECTION D4 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. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS ONCE THE EVALUATION OF THE DEVICE HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A TOTAL PARENTERAL NUTRITION (TPN) INFUSION THROUGH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), THEY IDENTIFIED THAT THE PICC LINE HAD SEPARATED FROM THE BROKEN SMARTSITE CONNECTOR. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL PT OR EVENT INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90304 | SMARTSITE NEEDLE-FREE VALVE | FPA | CAREFUSION CORPORATION | 2000E7D | 12076446 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PICC LINE, MANUFACTURER, MODEL AND LOT UNKNOWN |