Catalog Number RS22 |
Device Problems
Delivered as Unsterile Product (1421); Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/14/2023 |
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) 2023 and suture was used.Before use on the patient, it was reported that the primary package of the suture was found damaged prior to use.Changed another one to complete the surgery.No adverse patient consequences were reported.Additional information was requested.
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Manufacturer Narrative
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Product complaint # (b)(4).H6 component code: g07002 - device not returned.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.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.The following information was requested, but unavailable: could you please clarify if devices sterility was compromised or if any hole, tear, or puncture was observed in the package, open or incomplete seal? please clarify --contacted with the sales rep today via phone, please refer to the event description and photo, other information requested is unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
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Manufacturer Narrative
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Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.The returned sample determined that it was received, one open overwrap packet that pertained to product code rs22.The product code is double-armed.During analysis of the condition of the overwrap packet, it was noted that the overwrap was received open and contained one needle suture outside its packaging.In addition, the seal area was inspected and evidence of being properly sealed was found.No damages were observed in the packaging.As part of our quality process, the manufacturing records of this lot serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As per the condition of the returned sample, no conclusion could be reached as to what caused the reported complaint.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.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.Corrected data: g1.Manufacturer site address updated.
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Search Alerts/Recalls
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