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Catalog Number 2227 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Please confirm if the two reported drains were involved over the same procedure=>yes no product available for return.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Note: events reported on mw# 2210968-2024-04807, mw# 2210968-2024-04808.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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Event Description
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It was reported a patient underwent an unknown surgery on (b)(6) 2024 and a drain was used.During the procedure, the liquid leaked.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.Additional information has been requested.
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Manufacturer Narrative
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Product complaint # (b)(4).H3 evaluation: no sample has been or will be returned retention sample review : no negative observation was found.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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Search Alerts/Recalls
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