A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0342877, medical device expiration date: 2023-11-30, device manufacture date: 2020-12-07.Medical device lot #: 0350020, medical device expiration date: 2023-11-30, device manufacture date: 2020-12-15.
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H.6.Investigation: two photos were received by our quality team for evaluation.From the photos, the team was able to confirm the customer¿s experience.A device history record review found no non-conformances associated with this issue during production of this batch.This defect occurs when the ink on the print head is running low or needs to purged or there is a bad cable connection to the print head.There is a 100% vision system that checks for the lot number and other print on the package label.The packages that are missing printed information are rejected and separated into a sorting bin.All packages in the bin are inspected for product attributes.The acceptable packages are placed into a label dispenser, ready for placement into the shipper.If an operator fails to recognize the print error, a unit may be sent out with the reported defect.
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