(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.However, due to this complaint and other confirmed complaints of this nature, b.Braun medical has initiated a corrective action/ preventative action (capa) (b)(4) to address the issue of sheared/damaged catheters.If additional pertinent information becomes available a follow-up report will be filed.(b)(4).
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