(b)(4).The actual complaint product was not returned for evaluation.The device history records were reviewed for lot number aa5173n16 , the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).
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Halyard received a single report that referenced two different incidences, which were associated with separate units, involving one patient.This is the first of two reports.Refer to mdr # 89611594-2015-00177 for the second report.It was reported by a physician that on two occasions the jejunal portion of the transgastric jejunal tube fractured at the proximal portion just distal to the jejunal port area.The first tube was inserted on (b)(6) 2015 and the fracture occurred on (b)(6) 2015.The tube was replaced on (b)(6) 2015 and the incidence occurred again on (b)(6) 2015.There has been no patient injury or adverse effects.
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