Q2 EXTENSION SET, 17 INCH
Received Nov 28, 2017
Report 1649914-2017-00097 · MDR key 7064301
Device
Generic name
Intravascular Administration Set
Manufacturer
Quest Medical, Inc.Model number
95902Lot number
NOT PROVIDED
Product problems
- No Apparent Adverse Event
- Insufficient Device Problem Information
- No Apparent Adverse Event
- Insufficient Device Problem Information
Patient
Not reported
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS DISCARDED BY THE CUSTOMER AND THE LOT NUMBER WAS NOT PROVIDED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A CUSTOMER REPORTED AN ISSUE ENCOUNTERED WITH THE Q2 EXTENSION SET. THE REPORT STATES THAT THE PATIENT NOTIFIED THE REGISTERED NURSE THAT THE BITE INFUSION TUBING FILTER WAS LEAKING. ABOUT 1 SHEET SIZE OF PAPER SPILL ON BED SOAKED INTO SHEETS - PATIENT WAS NOT SITTING IN IT. ONE DROP OF BITE WAS FOUND ON THE PATIENT'S ARM. INFUSION WAS IMMEDIATELY STOPPED AND THE PHARMACY AND ATTENDING WERE NOTIFIED THERE WERE NO REPORTED PATIENT COMPLICATIONS RESULTING FROM THE ALLEGED ISSUE.
Additional Manufacturer Narrative
A DHR REVIEW COULD NOT BE COMPLETED BECAUSE THE DEVICE WAS DISCARDED BY THE END USER AND NO LOT NUMBER WAS PROVIDED. A REVIEW OF COMPLAINTS IN THE LAST 24 MONTHS IDENTIFIED ONE SIMILAR COMPLAINT WHICH COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS ALSO DISCARDED. A PROCESS REVIEW WAS CONDUCTED AND NO ANOMALIES WERE IDENTIFIED. A QUALITY ALERT HAS BEEN ISSUED TO MANUFACTURING PERSONNEL TO RAISE AWARENESS ABOUT THE ALLEGED ISSUE AS A PRECAUTIONARY MEASURE. QUEST MEDICAL WILL CONTINUE TO MONITOR COMPLAINT TRENDS.