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Catalog Number W31C |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a cabg on (b)(6) 2023 and bone wax was used.During the procedure, the bone wax was found out of the packaging and found un-usable.The procedure was delayed by 5 minutes.There were no adverse patient consequences reported.Additional information was requested.
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Manufacturer Narrative
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(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H6 component code: g07002 device not returned attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was the packaging unsealed? were there any rips, tears, or holes found in the device packaging? was the bone wax package opened by a staff member? was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time of 5 minutes? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? what is the patient¿s current status? note: related events reported via 2210968-2024-00234, 2210968-2024-00235, 2210968-2024-00236, 2210968-2024-00237, and 2210968-2024-00238.
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Manufacturer Narrative
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(b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information was requested, and the following was obtained: was the packaging unsealed? no , the product was in sealed packing only.Were there any rips, tears, or holes found in the device packaging? no such packing anomalies were found.Was the bone wax package opened by a staff member? yes, the package was opened by a hospital staff member was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time of 5 minutes? if yes, please explain.Yes, there was a delay in the surgery for a alternative to be found and used.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? no such instances were reported what is the patient¿s current status? normal.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Is there any complaint against the package? was there an issue with the sterility of the bone wax? why was the bone wax un-usable? is it known why the bone wax was found out of the packing? did the staff member open the package and just leave the bone wax out in error? please provide/explain any further details that could clarify this complaint.
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Manufacturer Narrative
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Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information was requested and the following was obtained: please provide/explain any further details that could clarify this complaint.I was informed that the bonewax seemed to be solidified and was no more malleable.
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Search Alerts/Recalls
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