Scrub tech upon opening the custom pack to prepare for the case observe large amounts of particulates in the sterile basin that was inside the pack.(b)(6) operating room #2 on (b)(6) 2019 about 0720 hrs.No staff or pt injured, this pack was destroyed and supplies pulled from stock to make up the sterile setup.(b)(4) submitted.Fda report filed.Certified scrub tech opened the pack, product sterile and packed in manufactured packaging expire on 11/01/2020, lot #1358662.Product should be free of foreign debris.Incident of this nature is not uncommon and is continued to be reported as they occur.Vendor poc for the (b)(6) notified.(b)(6).(b)(4).
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