All information was investigated and the reported loose or intermittent connection, difficulty/inability to flush and device contamination with chemical or other material was confirmed via returned device analysis.
The investigation determined that the reported loose flush port connection, difficulty/inability to flush and obstruction inside the flush port is the result of the observed flush port contamination with plastic piece.
The reported crack on the luer was likely due to the clear plastic inside the luer making it appear to be a crack.
The broken plastic piece was sent to the materials characterization lab for chemical analysis.
Results indicate the material is comparable to the sample 3 way plastic stopcock.
A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.
Additionally, a review of the complaint history identified no other complaints from the lot.
The investigation identified the contamination of the luer with a plastic piece as a potential product issue.
The issue is being addressed per internal operating procedures.
Abbott will continue to trend the performance of these devices.
|