FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE NEEDLE-FREE VALVE
MDR report key: 4210347
·
Received August 8, 2014
Report
- Report Number
- 9616066-2014-00833
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 29, 2014
- Report Date
- July 10, 2014
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K061285
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY NOTICED THAT THE SMARTSITE HAD A HOLE IN THE "SEPTUM" FOLLOWING USE. THIS LEAD TO BLOOD POURING FROM THE DEVICE. 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 |
|---|---|---|---|---|---|---|---|
| 468825 | SMARTSITE NEEDLE-FREE VALVE | ACCESS DEVICE | FPA | CAREFUSION CORPORATION | 2000E | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |