This report is a response to medwatch report # (b)(4) which was received by amt from the fda on 08/26/2019.Based on the provided information, the incident is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Complaint # (b)(4) was assigned to this report.Analysis of the returned device consisted of a visual and functional evaluation, as well as a device history review.Examination of the device determined that a small tear had occurred through the strap plug of the med-port.This allowed for the port to easily pop open and/or leak when pressurized during use.The exact cause for the tear in the plug is unknown at this time.We have attempted to replicate the tear in the lab using several methods, but have been unsuccessful in replicating the tear visualized in the returned product.Based on the provided information and the evaluation completed it is not believed to have been caused by a manufacturing defect.We will provide additional information to the fda if the device or additional information is able to be obtained and its analysis changes the conclusion of this report.
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