UNOMETER SAFETI PLUS WITH LUER-LOCK $ LUER
Received Mar 2, 2015 · Event occurred Feb 17, 2015
Report 3007966929-2015-00031 · MDR key 4563168
Device
Product problems
- No Flow
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
COMPLAINANT REPORTED THE DEVICE WAS IN THE PATIENT FOR THREE WEEKS AND ON (B)(6) 2015 IT WAS NOTED THE OPEN/CLOSE LEVER 'WAS STIFF AND DIFFICULT TO TURN AND WHEN IT WAS TURNED OPEN, URINE DID NOT FLOW DOWN' TO THE COLLECTION BAG. THE COMPLAINANT FURTHER REPORTED THE NURSE HAD TO REPLACE THE DEVICE BECAUSE, THE CHAMBER WAS 'GETTING FULL'.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.