The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on april 11, 2022.One physical sample was received for evaluation.The sample was visually inspected, and the reported condition was confirmed, the hub was disassembled from the wire.The sample was then activated with 10ml of water and the stylet was easily removed.A gemba walk was performed, and the manufacturing process was reviewed, all process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging, and inspections performed to the product.In addition, qc inspections are performed to the product for material release; and production personnel performs a 100% visual inspection during the packaging process in order to detect and discard any identified issues.Based on all available information and the investigation findings a definitive root cause could not be determined for the reported condition.It should be noted that a failure to activate the hydromer makes it difficult to remove the stylet from the feeding tube, and a hub detachment could occur.Please refer to the ifu (instructions for use) for the proper procedure for insertion of the feeding tube and extraction of the stylet.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.We will continue to monitor any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.
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