MalfunctionMJJ
RETROGUARD ARTERIAL SAFETY VALVE
Received May 4, 2018
Report 1649914-2018-00044 · MDR key 7489000
Device
Product problems
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE ALLEGED INCIDENT OCCURRED OUTSIDE OF THE US. THIS MEDWATCH IS BEING SUBMITTED BECAUSE QUEST MANUFACTURES A SIMILAR DEVICE IN THE US. AS OF DATE THE LOT NUMBER OF THE DEVICE WITH THE ALLEGED DEFECT HAS NOT BEEN PROVIDED BY THE CUSTOMER AND IT IS UNKNOWN IF THE PRODUCT WAS USED ON A PATIENT . AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A REPORT WAS RECEIVED REGARDING AN ALLEGED ISSUE WITH THE VALVE. THE REPORT STATES THAT PARTICULATE MATTER WHICH LOOKS LIKE METALLIC FRAGMENT WAS FOUND IN THE HOUSING OF THE VALVE.