(b)(4).Report source (b)(4).Complaint sample was returned and evaluated against the reported event.Visual examination of the 20 units returned found that 1 unit did not contain any debris, 15 units contained one piece of loose blue debris, 2 units contained two pieces of loose blue debris, 1 unit contained one black elongated fiber of loose debris, and 1 unit contained one gray clump of loose foreign debris.All loose blue and foreign debris were measured with tappi chart 25-2007-187-00-ce and were found to exceed the allowed 0.60 sq.Mm.Size per zpc 8.400 rev.52.Dhr was reviewed and no discrepancies were found.Investigation has concluded that the root cause is attributed to a manufacturing error.The exact source of the foreign debris cannot be determined but they were likely introduced during the packaging operation.The blue particles likely come from the excess flash generated during the molding process and/or during the trimming of this excess flash.During the packaging operation, the operator failed to identified non-conforming devices.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02475.
|