(b)(4).Baxter medical assessment: particulates found either on or potentially inside devices that are designed to be utilized inside blood vessels have much greater consequences for the surgical patient.As this device is intended to be used inside of blood vessels, particulate matter on or potentially inside this device has a potential to introduce the particulate directly into the vascular system.In a worst case scenario, this may lead to a compromise in blood flow through that vessel causing thrombosis or embolism.After consideration for potential harms and worst-case scenarios, an adverse health consequence is expected to result from this issue.A follow-up report will be submitted upon receipt and evaluation of the investigation results of the sample.
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(b)(4).Baxter (b)(4) completed the investigation.Sample evaluation was performed.Visual and stereomicroscope inspections of the sample confirmed the presence of the particulate matter.The samples were forwarded to baxter r&d belgium for analysis, which revealed the presence of a single, irregular, and colorless mass.The particulate material was identified as polydimethylsiloxane, which was firmly attached to the side wall of the shunt tab.Per baxter synovis, this is a material used to secure the knots of the tether.Batch review was performed and baxter synovis indicated that tier ii and tier iii batch records were reviewed; all specifications and requirements were met prior to release of the product.Per baxter synovis, this product is inspected for foreign matter at three (3) points during the manufacturing process.No manufacturing issue was found as the origin of this complaint.The source of the foreign matter cannot be determined.(b)(4) was closed and found to be effective for this issue.Baxter synovis continues to monitor this complaint issue.No trend was identified.This complaint will be kept on record for trending purposes.
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