MalfunctionEXR
UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received May 4, 2015
Report 3007966929-2015-00044 · MDR key 4749165
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158100410190Lot number
655189
Product problems
- Infusion or Flow Problem
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. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THE URINOMETER DID NOT DRAIN AT THE CONNECTION BETWEEN THE FOLEY CATHETER AND THE MEASURING CHAMBER. NO PATIENT COMPLICATIONS WERE REPORTED.