UNOMETER SAFETI PLUS - WITH LUER LOCK & LUER
Received Dec 8, 2014 · Event occurred Oct 8, 2014
Report 3007966929-2014-00111 · MDR key 4344917
Device
Generic name
Urinometer Mechanical
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
654706
Product problems
- Decoupling
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THE UNOMETER DOUBLE LUMEN TUBE BECAME DISCONNECTED FROM THE CHAMBER. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE ARE TWO ADDITIONAL CASES WITH SIMILAR DISCONNECTION PROBLEMS MANUFACTURED UNDER TWO DIFFERENT LOTS. ADDITIONAL MDR REPORTS WILL BE SUBMITTED FOR EACH CASE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.