RLV-2100 VACUUM RELIEF VALVE
Received Apr 23, 2020
Report 1649914-2020-00024 · MDR key 9990732
Device
Generic name
Cardiopulmonary Suction Control Device
Manufacturer
Quest Medical, IncModel number
4103202Catalog number
4103202
Lot number
050232
Product problems
- Leak/Splash
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS UNDERWAY. A FOLLOW UP MEDWATCH WILL BE SUBMITTED FOLLOWING COMPLETION OF INVESTIGATION. THE EVENT OCCURRED IN AN OUS COUNTRY. THE DEVICE IS SOLD BULK NON-STERILE TO OEM MANUFACTURERS FOR FURTHER PROCESSING.
Description of Event or Problem
A REPORT RECEIVED FROM A CUSTOMER REGARDING AN ALLEGED ISSUE WHICH OCCURED DURING USE OF THE DEVICE. THE REPORT STATES THAT THE VENT LINE HAD POSITIVE PRESSURE AND THE VALVE STARTED LEAKING. THE PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
THE COMPLAINT SAMPLE EVALUATED CONFIRMED LEAKING FROM THE PRESSURE RELIEF BAND AT AROUND 10PSI. THE SAMPLE WAS RECEIVED FROM THE CUSTOMER WITH A ZIP TIE PLACED AROUND THE PRESSURE RELIEF BAND. THE ZIP TIE PLACED BY THE CUSTOMER ON THE PRESSURE RELIEF BAND RESULTED IN THE BAND OPENING OR CURLING CAUSING THE PRESSURE TO ESCAPE AT A LOWER VALUE THAN INTENDED.