D.10 device available for eval yes, d.10 returned to manufacturer on: 2020-08-17.H.6.Investigation summary one photo and one 3ml safetyglide combo in an opened blister from batch 9287062 (p/n 305905) was received and evaluated.It was observed the ribs of the hub were damaged with small plastic fragments protruding outwards and the safety mechanism was disconnected, which was rejectable per product specification.Potential root cause for the broken safety mechanism defect is associated with the needle manufacturing process.The samples will be forwarded to the needle manufacturing site for evaluation and potential root cause determination.Bd columbus was able to identify the root cause for the defect occurred on the safetyglide assembly line.The plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the epoxy to fix it; after that, a plastic safety mechanism is assembled, then at the end the plastic shield is assembled to the part.In this case, the needle assembly mechanism was not properly assembled to the safety mechanism inducing the symptom reported.Based on the investigation and the analysis of the sample the symptom reported by the customer is verified.No corrective actions are required at this time.Bd will continue to monitor this lot and failure mode through monthly trending meetings.
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