(b)(4).Investigation summary: the analysis results found that the (b)(4) device was returned inside its package unopened.Upon visual inspection, it was observed that the blister from the packaging was damaged.It was noted to be broken and still adhered to the tyvek.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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.Additional information was requested and the following was obtained: did the damage to the packaging compromise the sterility of the device? no further information is available.
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