UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Feb 4, 2015 · Event occurred Jan 20, 2015
Report 3007966929-2015-00024 · MDR key 4487591
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
170548
Product problems
- Disconnection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE COMPLAINANT REPORTS THE UNOMETER SAFETI PLUS WAS CONNECTED TO THE PATIENT'S SILICONE URINARY CATHETER AT APPROXIMATELY 5:00 PM ON (B)(6) 2015 AND 'BECAME DISCONNECTED' FROM THE DEVICE WITHIN THIRTY MINUTES. THE COMPLAINANT FURTHER REPORTS THE DEVICE WAS DISCONTINUED AT APPROXIMATELY 5:30 PM ON (B)(6) 2015.
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. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).