MalfunctionEXR
UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Mar 9, 2015
Report 3007966929-2015-00032 · MDR key 4602805
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
170761
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT URINE FLOWED DIRECTLY INTO THE MAIN COLLECTION CHAMBER OF THE DEVICE, BYPASSING THE INITIAL CHAMBER. IT WAS FURTHER REPORTED THE DEVICE WAS DISCONNECTED FROM THE URINE CATHETER.
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.