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It was reported a patient underwent an unknown surgery on (b)(6) 2025 and a drain was used.The drain and the trocar needle have adhered.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 of product, drain had chip-off marks.
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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.Were the drains used on the patient? the event was found before use on the patient.If yes, was leakage detected? was the new drain placed surgically during a second procedure? unk.Could you kindly perform and document the follow-up attempt for the product return? will be shipped.Complaint sample review: complaint sample: total two complaint samples of drain with trocar were received for evaluation, both the products were inspected visually, below were detailed observations: product-1: no sticking mark was visible on trocar, but the drain had one chip-off mark.Product-2: no sticking mark was visible on trocar, but the drain had one chip-off mark.Representative samples: total 4 samples were received for evaluation; three random samples were checked visually, below were detailed observations: product-1&3: trocar had sticking marks, also the drain had chip-off marks.Product-2: no sticking mark was visible on trocar, drain also had no chip-off mark.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.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.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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