UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
Received Dec 15, 2014 · Event occurred Jan 1, 2014
Report 3007966929-2014-00131 · MDR key 4349675
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
15810130190Lot number
156456
Product problems
- Disconnection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADD'L INFO WAS REQUESTED, BUT NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem
IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THE DEVICES WERE DISCONNECTING FROM THE CATHETER. THE PERIOD OF TIME THE DEVICE WAS USED WHEN THESE INCIDENTS OCCURRED DIFFERED. THESE DISCONNECTIONS CAUSED URINE TO LEAK ON THE BED.