Abstract
Smiths Medical MD, Inc. received notice of an issue involving a PORTEX® Epidural Minipack (reorder number and lot number not provided). It was reported that the connector device became disconnected from the filter during use. One used flat filter and epidural connector were received for evaluation. Visual examination of the returned components determined that the locking connector had been pulled over the bar on the flat filter that secures the ring in place. The issue reported was determined to have been caused by the connection having been over-tightened during use. Examination of the components showed no evidence that the components returned were manufactured improperly. The device history record could not be reviewed as the lot number of the product could not be confirmed. No corrective action has been identified as a result of this reported issue. However, the manufacturing facility intends to update the product instructions to clarify better how the connector is attached and prevent over-tightening. We regret any inconvenience this issue may have caused and are grateful to Drs Philip and Bourne for bringing this issue to our attention.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
