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Product complaint # (b)(4).Additional information has been requested and received.What is the lot number? j2300020.Please perform and document the follow up attempt for product return.=>we regularly contact with sales rep about the device returning.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.¿ was the drain used on the patient? ¿ if yes, was leakage detected? ¿ was another drain needed to correct the situation? ¿ if yes, was the new drain placed surgically during a second procedure? h3 evaluation: complaint sample review : one complaint sample of drain with trocar was received for evaluation, inside an opened package.Product was inspected visually, below are the detailed findings: 1 trocar and drain were found separated, and, no negative observation.2 however, while drain was inspected by zooming, there was a cut mark visible on the drain surface.It is suspected that, the drain might have came in contact with some sharp tool used prior / during surgery.External factors like mishandling or improper usage at user end could not be ruled out.Therefore, further investigation of the received samples is not possible.As per standard practice, 100% functional test and 100% visual inspection was carried out, before and after packing of finished goods, prior to the product release.There was no scope to miss such defect, at manufacturing / release stage.Retention sample of complaint lot were checked and found satisfactory.Documents review : during investigation of complaint, batch review of in-process and final packaging inspections, as well as the manufacturing process is performed, these products are reported to be manufactured, inspected, and packaged in conformance with customer's specifications and have been found to be acceptable within all parameters.No discrepancy as per the reported defect is observed.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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, 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.
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