UNOMETER SAFETI PLUS WITH LUER-LOCK AND LUER
Received Jan 13, 2015 · Event occurred Dec 17, 2014
Report 3007966929-2015-00018 · MDR key 4421966
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158101210190Lot number
497671
Product problems
- Partial Blockage
Patient
Not reported
- Not Applicable
Narrative
Description of Event or Problem
THE COMPLAINANT REPORTS THE VALVE WITHIN THE CONNECTOR (TOWARDS THE INDWELLING CATHETER) WAS BLOCKED; STERILE WATER DID NOT PASS THE VALVE FROM THE INDWELLING CATHETER INTO THE URINOMETER CHAMBER. THE COMPLAINANT FURTHER STATES THE DEVICE WAS TESTED PRIOR TO USING ON A PT.
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. ADDITIONAL EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON 01/12/2015.