On initial mdr the h8 ¿initial use¿ was submitted in error, it should have been ¿reuse of reusable device¿ in the original mdr.A sample was not received at the manufacturing site for evaluation for the report of injector jammed; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information is available, therefore, the root cause for the customer complaint issue cannot be determined.The manufacturer internal reference number is: (b)(4).
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