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Catalog Number 0117310 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2022 |
Event Type
malfunction
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Event Description
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As reported, during a product set up on (b)(6) 2022, the bard/davol 3dmax light mesh was noted to be torn when opened from the package.It was reported that there was no damage noticed on inner pouch and outer package.There was no reported patient injury.
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Manufacturer Narrative
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As reported, the bard/davol 3dmax light mesh was found torn when opened from the package.The subject device is available for evaluation, however, at this time has not been received.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.If/when the sample is returned and evaluated, a supplemental mdr will be submitted.Not returned.
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Manufacturer Narrative
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As reported, the bard/davol 3dmax light mesh was found torn when opened from the package.The subject device is available for evaluation, however, at this time has not been received.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document sample evaluation results.Evaluation of the sample finds that there are multiple frays/tearing in the edge seal of the mesh, and visible blood contamination on the device which indicates physical handling of the mesh during attempted use.The found edge seal and mesh tearing condition is not indicative of the as manufactured condition.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause is most likely the result of handling and inadvertently occurred during user/device interface during attempted use of the mesh.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october, 2021.Updated fields: b4, b5, d4 (medical device lot # and medical device expiration date), d9, g3, g6, h2, h3, h4 (device manufacture date), 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.H3 other text : sample evaluated.
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Event Description
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As reported, during a product set up on 15-mar-2022, the bard/davol 3dmax light mesh was noted to be torn when opened from the package.It was reported that there was no damage noticed on inner pouch and outer package.There was no reported patient injury.Addendum: per additional information provided, the torn mesh was noted during set up.
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Search Alerts/Recalls
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