(b)(4).Date sent: 6/13/2023.B3: event year only reported: 2023.D4 batch #: x95348.Investigation summary the product was returned for evaluation.Visual inspection was conducted on the returned device.The device was returned sealed inside its original packaging.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.Upon visual inspection, it was observed that the tyvek from the packaging was damaged.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.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot/batch x95348, and no non-conformances were identified.
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