Q2 CHECKMATE EXTENSION SET
Received Feb 27, 2019 · Event occurred Jan 30, 2019
Report 1649914-2019-00009 · MDR key 8376214
Device
Generic name
Intravascular Administration Set
Manufacturer
Quest Medical, Inc.Model number
9545Catalog number
9545
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED COMPLAINT CONDITION IS UNKNOWN. QUEST WILL CONTINUE TO MONITOR COMPLAINT TRENDS.
Description of Event or Problem
A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE ENCOUNTERED DURING USE OF THE INTRAVENOUS ADMINISTRATION EXTENSION SET. THE REPORT STATES THAT THE MANIFOLD LEAKED DURING SURGERY RESULTING IN A DELAY IN PROCEDURE. NO PICTURE OF THE PRODUCT IS AVAILABLE AND THE DEVICE IS NOT AVAILABLE FOR RETURN.