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It was reported a patient underwent an unknown neurosurgery on an unknown date and a drain was used.The drain tube was damage.Another product was used to complete the case.When we send the sample to you, we will let you know its return date and tracking number.There were no adverse consequences to the patient.Further details are not provided.Upon receipt and analysis, a deep hole on the drain.
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Product complaint # (b)(4).Additional information provided: ·it was found that the tube was damaged during the surgery and another product was used to complete the case.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 the new drain placed surgically during a second procedure? =>unk - could you please provide the lot number? =>unk.- could you kindly perform and document the follow-up attempt for the product return?=>we regularly contact with sale rep about the device returning.- please provide the source or name of person providing answers to follow-up questions: =>(b)(6).H3 evaluation: complaint sample review: one complaint sample of drain with trocar was received for evaluation, product was inspected visually and in reference to the complaint details "drain tube was damage", product was checked visually and found that there was a deep hole on the drain.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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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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