(b)(4).Investigation summary: three photos were received by our quality team for evaluation.From visual inspection of these photos, peel-back was observed on the catheter tip in one photo and another photo shows a kinked catheter, verifying the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.A trend for the peel-back issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the bd neoflon device and prevent future occurrences of this type.As part of the action plan, changes to the catheter material and method of shaping the catheter tip are in the process of being implemented.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the probable root cause for the peel-back could be due to the tubing material.Reported needle stick injury: based on the verbatim, the reported needle stick injury happened during the third attempt on the child and the child jumped which resulted needle stick injury issue.The incident was due to product application.Reported catheter kink/ bent: as no sample was returned and it is not possible to perform any investigation on the reported catheter kink/bent based on the photos returned, a review of past 12 months quality notification was performed.No similar quality notification was raised for the reported defect.Therefore, the root cause cannot be determined.Complaint will be reopened when sample is returned.Capa #:(b)(4).Rationale: capa#(b)(4) was issued to review the tubing material.
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