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.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rees1267 showed one other similar product complaint(s) from this lot number.
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H11: 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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged introducer was confirmed, but the exact cause could not be determined from the photograph that was provided for investigation.The photo showed on microintroducer in a clear bag.Deformation was observed at the distal end of the introducer sheath.The material flared outward away from the external surface of the dilator tip.The sheath had not been split.The label with part number 1194108d4 and lot #rees1267 were observed in the photo.Since the reported damage was observed in the provided photo, the complaint was confirmed, but the exact mechanism of damage could not be determined.
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