Bd awareness date was reported incorrectly as (b)(6) 2014 on initial mdr.
The correct awareness date was (b)(6) 2017.
Samples or photos have not received for analysis of the incident in question.
Dhr/qn/ncmr review: assembled lot: 7151597, used in the claimed final product lot: 7151712 of insyte autoguard 20g x 1.
16 was analyzed for "needle retraction" and ¿part activation¿ tests, and were no evidenced failure in the activation of the part during analysis of these batches.
Bd was unable to confirm the incident in question.
As samples are not available for analysis of this complaint and as no objective evidence of this issue was evidenced during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to confirm this complaint.
Based on the investigations of this complaint, it was not possible to assign a root cause for the incident.
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