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Catalog Number 0115610 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As reported, upon opening the package of modified onflex mesh, a foreign material like hair was found.The subject device has been returned for evaluation.Initial evaluation of the sample found a foreign material (hair) present within the envelope as reported and appears brown in color.The sample evaluation is on-going at this time.When the sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 259 units released for distribution in april, 2022.
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Event Description
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As reported on 09-nov-2022, upon opening the bard/davol modified onflex mesh package, a foreign material like hair was found.There was no reported patient injury.
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Manufacturer Narrative
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As reported, upon opening the package of modified onflex mesh, a foreign material like hair was found.The subject device has been returned for evaluation.Initial evaluation of the sample found a foreign material (hair) present within the envelope as reported and appears brown in color.The sample evaluation is on-going at this time.When the sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in april, 2022.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.Further evaluation of the sample finds that the condition may have originated at manufacturing area during sealing/ inner packaging manufacturing process (since hair like foreign matter was found inside the tyvek envelope).Based on the sample evaluation, the complaint root cause was confirmed as manufacturing related.Awareness training was provided to all appropriate manufacturing personnel as a result of this complaint.Updated fields: b4, g3, g6, h2, h3, h6, h10.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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As reported on 09-nov-2022, upon opening the bard/davol modified onflex mesh package, a foreign material like hair was found.There was no reported patient injury.
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Search Alerts/Recalls
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