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Catalog Number Z771D |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.The surgeon had an unusual feeling during interrupted suturing.When the surgeon checked the product, it was found that the product was not a monofilament but was shaped like a blade.The color was pale purple when compared with the normal product.This was a control release needle.There were no adverse consequences to the patient.No further information was provided.
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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.Analysis summary: unopened sample multistrand of product code z771d was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.In order to evaluate the condition of the returned sample, the foil packet was open, the labeled winding former was examined, and the needle-sutures combination belong to product code z771d for pds suture violet monofilament.No anomalies or issues related to product mix was found.A manufacturing record evaluation was performed for the finished device sampal/ z771z20 batch number, and no non-conformances were identified.Related events captured via: 2210968-2022-05047, 2210968-2022-05048, 2210968-2022-05049,2210968-2022-05050, 2210968-2022-05051.
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Manufacturer Narrative
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Product complaint#: (b)(4).Date sent to the fda: 8/2/2022.Additional information was received: there were 4 samples from lot: sampal and 2 from lot: samrje.Same product code and characteristics.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.Related events captured via: 2210968-2022-05047, 2210968-2022-05048, 2210968-2022-05049,2210968-2022-05050, 2210968-2022-05051 and 2210968-2022-05052.Date sent to the fda: 8/2/2022.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.
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Manufacturer Narrative
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(b)(4).Date sent to fda: 08/05/2022.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 samrje/ z771z20 batch number, and no non-conformances were identified.(b)(4).Date sent to fda: 08/05/2022.
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Search Alerts/Recalls
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