On (b)(6) 2014, our distributor in (b)(6) reported that after approximately two to three dialysis sessions, the catheter was "without flow".The dialysis catheter was exchanged for another new from a different manufacturer.There was no report of patient harm or injury due to the event.It was reported the disposable device is available for return to the manufacturer for evaluation.
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It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Complaint # (b)(4).
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