A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One sample without original packaging was received for evaluation.The sample was visually inspected per procedure.The reported issue was confirmed; the hub was disassembled from the wire (stylet).During the evaluation of the returned device, the hydromer was activated and the stylet was removed without resistance.The most likely root cause for the reported issue is due to inadequate use of the procedure if the instructions for use were not followed correctly such as a failure to activate the hydromer which makes it difficult to remove the stylet from the feeding tube resulting in a hub detachment.The instructions for use (ifu) for the proper procedure for insertion of the feeding tube and extraction of the stylet state "using a syringe, inject approximately 10 cc of water into the tube to activate the hydromer coating".A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
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