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It was reported a patient underwent an unknown surgery on an unknown date and a drain was used.The drain had adhered to the trocar needle when the package was opened and tried to use.A hole was created when separated them.Another product was used to complete the case.There were no adverse consequences to the patient.Further details are not provided.Upon receipt and analysis, the drain was observed to have a sticking mark visible on trocar, also the drain had similar chip-off mark on upper surface.
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Product complaint # (b)(4).Additional information has been requested and 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? =>unk.If yes, was leakage detected? was another drain needed to correct the situation? unk.If yes, was the new drain placed surgically during a second procedure? please perform and document the follow up attempt for product return.The device has been received at sukagawa and will be shipped.Please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) - kana takahashi.H3 evaluation: complaint sample review: actual sample: one complaint sample of drain with trocar was received for evaluation, product was inspected visually and found that there was a sticking mark visible on trocar, also the drain had similar chip-off mark on upper surface but no hole was identified.Representative sample: complaint sample received total two complaint samples in well intact pouches (originally packed) were received for evaluation, both the samples were opened and checked visually for defect.No negative observation was identified.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.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.Retention sample review: no negative observation was found.Review of defective sample's image / video: not applicable, as there was no complaint sample image / video received for evaluation.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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