One customized 6.5mm id uncuffed flextend device was returned due to the neck flange eyelet breaking.Upon visual inspection of the returned device, it was confirmed the device's eyelet was torn completely through.Pictures of the returned device were sent.Per the customized warning statement in section 4.10 "guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.A damaged eyelet can result in decannulation of the tracheostomy tube.The product is 100% inspected after manufacturing, prior to shipping to the customer.The dhr for lot number was reviewed.The product was manufactured at the southington ct facility and passed all manufacturing and quality inspections.There were no non-conformances or abnormalities found in the dhr review.Two devices were manufactured with this lot number.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).No product information has been provided to date.
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