(b)(4).Batch #: unk.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 uv120 device was returned with its packaging.The boxes were visually inspected.They were bent and damaged and the device was noted to be damaged in the sleeve area.Upon visual inspection, it was observed that the tyvek from the packaging was damaged (hole).The damage found compromised the device's sterility.The damage observed on the package was most likely caused due to damage noted on the boxes.The reported event was confirmed.Due to the damages found on the packaging, 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.Please reference the instructions for use for more information.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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