UNOMETER 500 - URINEMETERS
Received Dec 10, 2014 · Event occurred Oct 28, 2014
Report 3007966929-2014-00128 · MDR key 4340291
Device
Generic name
Urine Flow Rate Measuring Non-electr
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
162015
Product problems
- Occlusion Within Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE ARE A TOTAL OF NINE (9) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE NINE SEPARATE 3500A FORMS HAVE BEEN GENERATED TO ADDRESS THE OTHER CASES. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem
THE HLTH CARE PROFESSIONAL STATED THERE WAS ONE OCCURRENCE WHERE THE 40 MILLILITER BURETTE WAS OPENED FOR DRAINING; HALF OF THE CONTENTS DRAINED FREELY INTO THE END BAG AND THEN STOPPED DRAINING. IT WAS FURTHER STATED "THE STAFF MEMBER THEN 'WIGGLED AND TWISTED' THE TOP AREA OF THE BURETTE UNTIL FINALLY IT DRAINED THE REMAINDER OF THE URINE INTO THE END DRAINAGE BAG."