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 mar 31, 2022.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H4 (device manufacture date).H6 (identification of evaluation codes 10, 3331, 3259, 25).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 3331 - analysis of production records.Investigation findings: 3259 - improper physical structure.Investigation conclusions: 25 - cause traced to manufacturing.The affected sample was returned and confirmed to have a marking on the outside of the reservoir housing.Reservoir retention housing from three lots were inspected with none of the housings displaying any markings/scratches in and around the affeted area.On the production floor, 13 units were visually inspected prior to leak test.The 13 units were noted to have no markings/scratches in the affected area.The 13 units were then leak tested and put on the final assembly table by the operator which involves placing the units on a mounting post.The units went around the table to final inspection where they were visually inspected for any damage.Of the 13 units, 4 were noted to have slight scratches.A rejected unit was used to re-create the reported event.The unit was placed on the table using normal force and purposefully contacted the mounting post.A marking was noted on the housing that is similar to the reported event.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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