Other, other text: additional information added to h6 and h10.This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual and functional testing were performed.Visual examination of device displayed no evidence of bent/bowed cannula or cannula bevel tip damage.Visual examination of the device displayed evidence of damage to the locking distal end of the guard with no bent/bowed cannula or cannula bevel tip damage noted.The damage to the guard component was sufficient to prevent normal advancement and engagement of the safety locking mechanism, resulting in the cannula tip protruding beyond the guard nose.The root cause of the reported issue was found to be a manufacturing issue.Actions were taken to mitigate the reported issue: the complaint was communicated to appropriate personnel.
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