UNOMETER SAFETI PLUS WITH LUER-LOCK & LUER
Received Apr 22, 2015 · Event occurred Apr 1, 2015
Report 3007966929-2015-00038 · MDR key 4723522
Device
Product problems
- No Flow
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THE URINE DID NOT FLOW FROM THE URINARY CATHETER INTO THE URINOMETER. THE DEVICE WAS DISCONNECTED AND REPLACED. 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 FIVE DEVICES, THEREFORE A SEPARATE FDA FORM 3500A WILL BE DRAFTED FOR EACH DEVICE.