UNOMETER SAFETI PLUS - WITH LUER LOCK & LUER
Received Dec 8, 2014 · Event occurred Oct 8, 2014
Report 3007966929-2014-00112 · MDR key 4344906
Device
Generic name
Urinometer, Mechanical
Manufacturer
Unomedical Ltd.Model number
158101310190Lot number
654706
Product problems
- Decoupling
Patient
Unknown
- No Known Impact Or Consequence To Patient
- No Clinical Signs, Symptoms or Conditions
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.