UNOMETER 500, URINE METER
Received Dec 9, 2014 · Event occurred Nov 6, 2014
Report 3007966929-2014-00122 · MDR key 4339760
Device
Product problems
- Disconnection
Patient
Unknown
- No Known Impact Or Consequence To Patient
- Insufficient Information
Narrative
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).
Description of Event or Problem
A UNIT CLERK REPORTED ON BEHALF OF STAFF NURSES THE DEVICE'S TUBE DISCONNECTED FROM THE PATIENT'S CATHETER DURING USE. AS A RESULT URINE HAS LEAKED ONTO THE PATIENT'S BED.