UNOMETER SAFETI PLUS - WITH LUER LOCK AND LUER
Received Jan 16, 2015 · Event occurred Dec 23, 2014
Report 3007966929-2015-00020 · MDR key 4432402
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
170548
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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. NO ADDITIONAL PATIENT/EVENT DETAILS WERE AVAILABLE AT THE TIME OF THIS REPORT. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE URINOMETER WAS ATTACHED TO THE PATIENT'S CATHETER; WHEN THE PATIENT WAS TURNED, APPROXIMATELY 2 HOURS LATER, THE NURSE NOTED THE URINOMETER HAD BECOME DETACHED FROM THE CATHETER. AS A RESULT, THE PATIENT'S BED LINENS WERE WET. THE URINOMETER WAS DISCONTINUED AT THAT TIME AND REPLACED WITH A LEG BAG.