MalfunctionEXR
UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
Received Feb 12, 2015
Report 3007966929-2015-00028 · MDR key 4528097
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical LtdModel number
158101310190Lot number
166482
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE PT'S URINE FLOWED DIRECTLY INTO THE MAIN COLLECTION CHAMBER OF THE URINOMETER, BYPASSING THE INITIAL FIVE HUNDRED MILLILITER CHAMBER. UPON DISCOVERY, THE DEVICE WAS DISCONTINUED. NO PT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.