There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot#: 1347596, medical device expiration date: 2023-12-31, device manufacture date: 2022-01-11, medical device lot#: 1351779, medical device expiration date: 2023-12-31, device manufacture date: 2022-01-11.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for damaged luer with the incident lot was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode damaged luer.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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