UNOMETER SAFETI PLUS WITH LUER-LOCK & LUER
Received Jun 1, 2015 · Event occurred Jan 26, 2015
Report 3007966929-2015-00049 · MDR key 4810782
Device
Product problems
- Restricted Flow rate
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THE URINOMETER 'MEASURING CHAMBER EMPTIES SLOWLY TO THE COLLECTOR BAG, INDEPENDENTLY OF' THE POSITION OF THE OPEN/CLOSE LEVER. 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 THIS MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS COMPLAINT INVOLVES FIVE DEVICES, THEREFORE A SEPARATE FDA FORM 3500A WILL BE DRAFTED FOR EACH DEVICE.