Operator of device is unknown.No information has been provided to date.Catalog number is unknown.Udi information is unknown.Manufacturing site address is unknown.Premarket (510k) number is unknown.A device history record (dhr) review was conducted at the supplier site.A product sample was received for evaluation.Visual and functional testing were performed by the supplier.The root cause of the reported issue was found to be related to customer care.It has been determined that the damage occurs during shipments of single cartons of pre-paks from the distributors to end users.Unpalletized prepak carton shipping procedures, has been provided to smith's medical several times over the last five years.This procedure details packaging the single packs of discs in an overpack with shipping popcorn.This will prevent damage to the pre-paks.The box the pre-packs are packaged in cartons that clearly states they are fragile this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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