Model Number EZF21A |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/25/2014 |
Event Type
No Answer Provided
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Event Description
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It was reported by warehouse in (b)(6) that on the ez glide aortic cannula "unknown fiber-like particulate was found inside the package during incoming inspection." this was found during (b)(4) incoming inspection and never had contact with the patient/hospital.
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Manufacturer Narrative
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The device evaluation is currently in process into root cause.
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Manufacturer Narrative
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Evaluation: the particulate was found to measure at 1700 m by 20 to 80 m in width.And is consistent with rayon.The root cause of the device being distributed with particulate in the sterile barrier is unknown.A manufacturing defect has been confirmed.A capa has been initiated to investigate and implement corrective actions for particulate.The trend for this complaint type is in control.Manufacturing records were reviewed and there were no reported nonconformances.The instructions for use, training and risk control measures are appropriate at this time.Trends will continue to be monitored on through the edwards quality system.
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Search Alerts/Recalls
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