Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use? no, device returned to manufacture: no.Investigation summary: as no physical or picture samples were available and a lot number was unknown for this incident, neither a sample evaluation nor a production history review could be completed.During the molding process and the assembly process, inspections and tests are performed to ensure product meets specifications.These inspections and tests include visual inspection for faulty parts, quality dimension measurements, assembly verification, welding verification, cannula length verification using a caliper gauge, and functionality testing.Based on the limited investigation, a cause for the reported issue could not be determined.It was determined that no capa is required: taking into account the information provided is not possible to establish the root cause.
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