inforMED
MalfunctionEXR

UNOMETER SAFETI PLUS W/ LUER-LOCK AND LUER-SLIP

Received Dec 18, 2014 · Event occurred Nov 18, 2014

Report 3007966929-2014-00132 · MDR key 4355742

Device

Manufacturer

Unomedical Ltd.

Model number

15810120190

Lot number

154054

Product problems

  • Mechanical Problem
  • Device Operates Differently Than Expected
  • Positioning Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

A NURSE REPORTED THAT THE URINE DOES NOT FLOW SPONTANEOUSLY WITHOUT THE MANIPULATION OF THE CIRCUIT.

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.