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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that was received one open box that pertain to product code vcp311h.Upon the visual inspection of the received box, it was found that contained thirty-four packets relabeled instead of thirty-six.As per product requirements, the box should contain thirty-six packages.In addition, it was noted that the tab dispenser was removed from the box.As part of our quality process, the manufacturing records of this lot-batch number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached on the cause of the reported event.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device and no non conformances / manufacturing irregularities related to the malfunction were identified.Additional information was requested, and the following was obtained via: were there any patient consequences? no.
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It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.Before use on the patient, it was reported that our distributor did incoming goods checking, there was two packages of product less than expected in the box when just opened.There should be thirty-six packages of products in the box, but actually there were only thirty-four packages of products.Enclosed please find defect photo.Visual analysis of the returned sample revealed that was received one open box that pertain to product code vcp311h.Upon the visual inspection of the received box, it was found that contained thirty-four packets relabeled instead of thirty-six.As per product requirements, the box should contain thirty-six packages.In addition, it was noted that the tab dispenser was removed from the box.No additional information could be provided.No adverse patient consequences were reported.No additional information was requested.
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