Q2 CHECKMATE EXTENSION SET
Received Oct 29, 2014 · Event occurred Sep 23, 2014
Report 1649914-2014-00051 · MDR key 4211576
Device
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING A VISIT WITH THE HOSPITAL FACILITY, A QUEST MEDICAL REPRESENTATIVE WAS INFORMED OF SOME ISSUES WITH A FEW FLUID DELIVERY PRODUCTS. THE REPORT STATED THAT WHEN SYRINGES ARE ATTACHED TO THE FLUID DELIVERY DEVICE AND THE SET-UP IS BUMPED DURING A PROCEDURE, THE PORTS HAVE DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE LOT NUMBER OF THE DEVICE WAS NOT KNOWN. ANY SAMPLES WERE DISPOSED OF BY THE HOSPITAL AND NOT GIVEN TO THE MANUFACTURER FOR ANALYSIS.
Additional Manufacturer Narrative
QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.