Q2 EXTENSION SET WITH Y-SITE, 17 INCH
Received Sep 9, 2013 · Event occurred Jul 18, 2013
Report 1649914-2013-00051 · MDR key 3410429
Device
Generic name
Intravascular Administration Set
Manufacturer
Quest Medical, Inc.Model number
95902Lot number
0437793F06
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE HOSPITAL NOTIFIED THE MANUFACTURER THAT THE NURSING UNIT ENCOUNTERED AN ISSUE WITH AN INTRAVASCULAR ADMINISTRATION SET INCLUDING THE Q2 EXTENSION SET MANIFOLD. IT WAS ONLY REPORTED THAT THE SET HAD A LEAK AT THE MANIFOLD FILTER. THE PATIENT WAS RECEIVING CHEMOTHERAPY WHEN THE ALLEGED ISSUE WAS DISCOVERED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SET WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.
Additional Manufacturer Narrative
(B)(4). ALTHOUGH THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, QUEST MEDICAL, INC. HAS ALREADY INITIATED AN INVESTIGATION ON THIS ALLEGED ISSUE AND THIS EVENT IS ADDED TO THAT INVESTIGATION. THE INVESTIGATION IS STILL UNDERWAY.