UNOMETER SAFETI PLUS - WITH LUER - LOCK & LUER
Received Apr 23, 2015 · Event occurred Apr 7, 2015
Report 3007966929-2015-00040 · MDR key 4726809
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Product problems
- No Flow
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED, AFTER 18 DAYS OF USE, THE URINOMETER OPEN/CLOSE LEVER WAS IN THE OPEN POSITION; HOWEVER, THE 'TOTAL URINE CONTENT DID NOT FLOW' INTO THE COLLECTION BAG AND REQUIRED 'ADDITIONAL MANIPULATION'. THE DEVICE WAS DISCONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.
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 THS MALFUNCTION. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).