This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on oct 29, 2018.(b)(4).An investigation wasn't able to be performed as the sample was not returned and the lot information was not made available, therefore an applicable retention sample investigation is not possible.Replication testing has found that this crack appears on the part when the white connector is over tightened on a port.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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