UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Apr 22, 2015 · Event occurred Apr 8, 2015
Report 3007966929-2015-00033 · MDR key 4723525
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158100410190Lot number
655189
Product problems
- Infusion or Flow Problem
Patient
Not reported
- Urinary Retention
Narrative
Description of Event or Problem
IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH 'SEVERE BURNS' AND, ON AN UNKNOWN DATE, WAS CATHETERIZED. AN URINOMETER WAS CONNECTED TO THE PATIENT'S CATHETER. POST-CONNECTION, THE NURSE NOTED THE URINOMETER WAS NOT DRAINING AT THE CONNECTION BETWEEN THE FOLEY CATHETER AND THE MEASURING CHAMBER AND THE PATIENT 'SHOWED [SIGNS OF] URINARY RETENTION'. AFTER MANIPULATING THE DEVICE, 'FIVE HUNDRED MILLILITERS OF URINE EXIT [ED] THE BODY'. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
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 ONE KNOWN DEVICE AND AN UNKNOWN NUMBER OF DEVICES WITH THE SAME COMPLAINT; THEREFORE, ONE FDA 3500A WILL BE SUBMITTED FOR THE KNOWN DEVICE AND ONE FDA 3500A FOR THE UNKNOWN NUMBER OF DEVICES.