CHECKMATE INTRAVASCULAR ADMINISTRATION SET
Received Oct 29, 2014 · Event occurred Sep 25, 2014
Report 1649914-2014-00053 · MDR key 4211644
Device
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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.
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. THIS REPORT STATED THAT WHILE THE DEVICE IS BEING REMOVED FROM THE STERILE PACKAGING, PART OF THE DEVICE DETACHES. IT WAS REPORTED THAT OCCASIONALLY THIS HAPPENS WHILE THE NURSE IS ATTEMPTING TO SPIKE THE IV BAG. THE REPORT STATED THAT THE DEVICE DETACHES AT THE LUER LOCK LOCATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE LOT NUMBER OF THE DEVICE WAS NOT NOTED BY THE HOSPITAL. ANY SAMPLE(S) WERE DISPOSED OF BY THE HOSPITAL AND NOT GIVEN TO THE MANUFACTUER FOR ANALYSIS.