(b)(4).Investigation summary the analysis results found that the harh36 device was returned along with the tyvek, but the blister was not returned for analysis.Upon visual inspection of the tyvek, it was observed that a piece of blister was broken and still adhered to it.A manufacturing record evaluation was performed for the finished device and the manufacturing criteria were met prior to the release of this lot/batch.Due to the damages found on the blister, a possible cause for this condition is due to improper handling during transit or storage.It appears that the package hit a hard surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.
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