MalfunctionEXR
UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Jan 7, 2015 · Event occurred Dec 15, 2014
Report 3007966929-2015-00002 · MDR key 4397571
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
15810131019CLot number
654706
Product problems
- Detachment Of Device Component
Patient
Not reported
- Not Applicable
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE 'TESTING THE DEVICE IN THE OFFICE TO VERIFY THE RESISTANCE OF THE DOUBLE LUMEN TUBE THE TUBING BROKE FREE FROM THE CHAMBER IMMEDIATELY WITH LOW STRENGTH'.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE DEVICE WAS NOT USED ON A PATIENT. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED.