FDA Adverse Event
Malfunction
Summary report: N
NAVILYST MEDICAL
MDR report key: 3982806
·
Received June 13, 2014
Report
- Report Number
- 1317056-2014-00037
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- May 14, 2014
- Report Date
- May 16, 2014
- Manufacturer
- NAVILYST MEDICAL
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FLUID DELIVERY SET HAS BEEN RETURNED FOR EVAL. AS THIS ITEM IS PURCHASED BY NAVILYST MEDICAL, WE HAVE FORWARDED THE SAMPLE TO OUR SUPPLIER, (B)(4), ALONG WITH A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). UPON THE COMPLETION OF OUR INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
AS REPORTED BY NAVILYST MEDICAL'S DISTRIBUTOR IN (B)(6), WHILE PRIMING A FLUID DELIVERY SET WITH SALINE, FOREIGN MATTER/HAIR WAS NOTED WITHIN THE DRIP CHAMBER. THE FLUID DELIVERY SET WAS FURNISHED IN A NAVILYST MEDICAL CONVENIENCE KIT. THE DEVICE WAS NOT USED ON A PT, AND WAS RETURNED TO NAVILYST MEDICAL FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351328 | NAVILYST MEDICAL | CONVENIENCE KIT | LJS | NAVILYST MEDICAL | NA | 4696162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |