UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Dec 31, 2014 · Event occurred Nov 26, 2014
Report 3007966929-2014-00137 · MDR key 4382150
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
159538
Product problems
- Occlusion Within Device
Patient
Unknown
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
Narrative
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. NO ADDITIONAL PT OR EVENT DETAILS HAVE BEEN PROVIDED TO DATE. ADDITIONAL INFO WAS REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014.
Description of Event or Problem
THE COMPLAINANT STATES, SHE HAD DIFFICULTY EMPTYING THE UNOMETER SAFTI PLUS BURETTE INTO THE BOTTOM DRAINAGE BAG. AFTER APPROXIMATELY EIGHT (8) TO TEN (10) ATTEMPTS OF TURNING THE TAP, THE BURETTE THEN DRAINED INTO THE BOTTOM DRAINAGE BAG. THE UNOMETER SAFTI PLUS WAS IN USE APPROXIMATELY THREE (3) DAYS WHEN THE FAULT WAS NOTED. THE UNOMETER SAFTI PLUS UNIT WAS REMOVED AND REPLACED WITH ANOTHER UNOMETER SAFTI PLUS UNIT.