RETROGUARD ARTERIAL SAFETY VALVE
Received Nov 28, 2017
Report 1649914-2017-00100 · MDR key 7064302
Device
Generic name
Cpb Check Valve
Manufacturer
Quest Medical, IncModel number
4007100Catalog number
4007100
Lot number
0521126S05
Product problems
- Particulates
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A CUSTOMER REPORTED AN ISSUE WITH THE VALVE. THE REPORT STATES THAT WHILE PRIMING, THE MEDICAL STAFF FOUND A PARTICULATE MATTER COLORED IN BLACK IN THE VALVE. THE LENGTH OF THE PARTICULATE MATTER IS ABOUT 2MM (ABOUT 0.3MM²).
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED BUT A PICTURE OF THE DEVICE SHOWING THE ISSUE WAS SENT. REVIEW OF THE PICTURE CONFIRMED PRESENCE OF PARTICULATE MATTER. QUEST MEDICAL HAS IMPLEMENTED SEVERAL CONTROLS TO PREVENT THIS ISSUE INCLUDING MAINTENANCE OF AN ISO CLASS 8 MANUFACTURING ENVIRONMENT, EMPLOYEE GOWNING AND UNIFORM PROCEDURES, ROUTINE CLEANING, BATCH TO BATCH LINE CLEARANCE ACTIVITIES AND MANUFACTURING SURFACE CLEANING. PARTICULATE COUNT, TEMPERATURE AND HUMIDITY IN THE CLEAN ROOM IS CONSTANTLY MONITORED IN ACCORDANCE WITH INTERNAL ENVIRONMENTAL MONITORING PROCEDURES. THE ROOT CAUSE IS UNKNOWN. AS A PROACTIVE MEASURE, QUEST MEDICAL HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE. NO FURTHER SUPPLEMENTS WILL BE SUBMITTED UNLESS NEW SIGNIFICANT FINDINGS EMERGE.