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 (b)(6), 2022.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration 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, 11, 3331, 3259, 4307) type of investigation #1: 10 - testing of actual/suspected device type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer type of investigation #3: 3331 - analysis of production records investigation findings: 3259 - improper physical structure investigation conclusions: 4307 - cause traced to component failure the affected sample was returned and confirmed to have a marking on the outside of the reservoir housing.Reservoir retention housing lot numbers 020521a, 020821a, and 021321a were inspected with none of the housings displaying any markings/scratches in and around the affected 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.Using k4855w (final inspection and packaging in-process inspection criteria) that states, no scratches (outside blood contact area) = 10mm, the mark was measured and found to be within specification.A representative retention sample was inspected and noted to have not have any markings or abnormalities on the reservoir housing.Upon evaluation of the returned sample and re-creating the reported event, the complaint is confirmed.The damage seen on the returned sample, likely occurs during the manufacturing process when the operator puts the unit on the final assembly table and inadvertently contacts the mounting post.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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