UNOMETER SAFETI PLUS-WITH LUER-LOCK & LUER
Received Dec 9, 2014 · Event occurred Nov 6, 2014
Report 3007966929-2014-00117 · MDR key 4339781
Device
Product problems
- Occlusion Within Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A UNIT CLERK REPORTED ON BEHALF OF STAFF NURSES THE UNITS ARE NOT ALLOWING URINE TO DRAIN THROUGH THE TOP CHAMBER. AS A RESULT URINE HAS LEAKED ONTO PATIENT'S BEDS.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE ARE FIVE (5) ADDITIONAL CASES WITH SIMILAR PROBLEMS MANUFACTURED UNDER THE SAME LOT. ADDITIONAL MDR (3500A) REPORTS WILL BE SUBMITTED FOR EACH CASE. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. (B)(4).