UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Jun 3, 2015 · Event occurred May 5, 2015
Report 3007966929-2015-00051 · MDR key 4817924
Device
Product problems
- Leak/Splash
- Unable to Obtain Readings
- Defective Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE NURSE REPORTS THE UNOMETER SAFETI OPEN/CLOSE LEVER IS IN THE CLOSED POSITION (IN ORDER TO MEASURE URINE OUTPUT) HOWEVER, AFTER ONE HOUR IT IS OBSERVED THE MEASUREMENT CHAMBER IS EMPTY; URINE FLOWS INTO THE COLLECTION BAG MAKING IT IMPOSSIBLE TO OBTAIN THE URINE MEASUREMENT.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THIS TIME OF THE REPORT. 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. THIS COMPLAINT INVOLVES TWO DEVICES, THEREFORE A SEPARATE FDA FORM 3500A WILL BE DRAFTED FOR EACH DEVICE.