UNOMETER SAFETI PLUS WITH LUER-LOCK & LUER
Received Apr 22, 2015 · Event occurred Apr 8, 2015
Report 3007966929-2015-00034 · MDR key 4723519
Device
Product problems
- Infusion or Flow Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
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.
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.