Product complaint #: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.Component code: g07002.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that it was received one empty foil, one folder, a needle, and some suture pieces that pertain to product code: nw9248.Upon visual assessment of the needle, the swage and attachment area was noted to be as expected.The barrel hole was examined under 20x magnification and the remnant suture was observed.In addition, the suture pieces have begun with a degradation process caused by exposure to the environment.The foil was visually inspected, and excessive wrinkles and holes in the cavity were observed due to handling.Per the sample condition, the functional test cannot be performed.As part of the ethicon 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.Additional investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional test evaluation were conducted on the returned devices.Visual analysis of the returned sample determined that it was received six unopened samples that pertain to the product code: nw9248.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon 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.Related medwatch reports: 2210968-2023-01252.
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