Q2 EXTENSION SET WITH Y-SITE, 17 INCH
Received May 21, 2013 · Event occurred Apr 1, 2013
Report 1649914-2013-00029 · MDR key 3130092
Device
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
REFERENCE: (B)(4). DEVICE EVALUATION: 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. QUEST MEDICAL, INC. HAS LIMITED INFO 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
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 INFUSATE WAS NOT IDENTIFIED; HOWEVER, NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE ALLEGED EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE SET WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.