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.The following information was requested, but unavailable: if possible, please provide the lot number: contacted with the sales rep today via phone and the information requested is unknown.H3 device analysis: he product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that it was received one needle and suture that pertain to product code tpw20.In addition, the suture was not received.Upon visual analysis of the returned needle, the barrel hole was examined under 20x magnification, and no remnant suture was found.Also, the suture was not received for analysis.Due to returned condition of the sample cannot functional test was performed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.
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