(b)(4).Batch #: unknown.Date of event is 2021.Event day and event month were not reported.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined that the el5ml device was returned unopened.Upon visual inspection of the tyvek, some cuts were observed on it, as if its cuts were performed with a cutter.Also, the blister was noted broken in one of the corners and the remainder was observed still adhered to tyvek.The reported complaint was confirmed.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.All ees product is 100% inspected prior to release.As part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
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