Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.
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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 december 22, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date) d9 (updated device availability) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h3 (updated device evaluated by manufacturer) h4 (device manufacture date) h6 (identification of evaluation codes 11, 3331, 4114, 3221 4315) the affected sample was not returned for evaluation, nor were any pictures provided; therefore, a thorough investigation could not be performed.A representative retention sample from the same lot number was obtained and inspected.There were no anomalies noted with the device.Without the returned device or pictures, a definitive root cause could not be identified.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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