RLV-2100 VACUUM RELIEF VALVE
Received Feb 6, 2020
Report 1649914-2020-00006 · MDR key 9678603
Device
Generic name
Cardiopulmonary Suction Control Device
Manufacturer
Quest Medical, IncModel number
4103202Catalog number
4103202
Lot number
056972
Product problems
- Leak/Splash
- Device Slipped
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WILL BE EVALUATED WHEN IT IS RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE EVENT OCCURRED IN AN OUS COUNTRY. THE DEVICE IS SOLD BULK NON-STERILE TO OEM MANUFACTURERS. THIS MEDWATCH HAS BEEN SUBMITTED BECAUSE A SIMILAR DEVICE IS MARKETED BY QUEST MEDICAL IN THE US.
Description of Event or Problem
A REPORT RECEIVED FROM A CUSTOMER STATES THAT THE PLASTIC COLLAR SLIPPED OFF AND WAS LEAKING UNDER NO PRESSURE. THERE WERE NO PATIENT COMPLICATIONS.
Additional Manufacturer Narrative
THE COMPLAINT SAMPLE WAS EVALUATED AND LEAKING WAS SEEN AT NO PRESSURE. THE LEAKING WAS AS A RESULT OF THE RELIEF BAND SLIPPING OFF ITS ORIGINAL POSITION, THEREBY EXPOSING THE PRESSURE RELIEF HOLES. NO DEFINITIVE ROOT CAUSE HAS BEEN ESTABLISHED. A POTENTIAL ROOT CAUSE IS THE PRESSURE RELIEF BAND SLIPPING WHEN THE CUSTOMER ATTACHED TUBING TO THE VALVE .AS PART OF THE MANUFACTURING PROCESS, THESE DEVICES ARE 100% TESTED FOR RELIEF BAND OPENING. THE ROOT CAUSE OF THE REPORTED COMPLAINT IS UNKNOWN AND IS NOT CONFIRMED AS MANUFACTURING RELATED.