Model Number DIIFEMII020A |
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 02/04/2014 |
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 duraflo femoral arterial cannula "unknown fiber-like particulate was found inside the package during incoming inspection." this was found during (b)(6) 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: fibers measure approximately 14mm in length with a width ranging from 20- 40¿m in size.The ft-ir data is consistent of rayon.This report is a confirmed manufacturing defect and root cause is being addressed through capa.Manufacturing records were reviewed and there were no related manufacturing non-conformances.A technical summary has been initiated to address patient safety risk and to summarize the analysis of returned products to assist in ongoing corrective actions.Instructions for use remain appropriate.Trends will continue to be monitored through the edwards quality systems.
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Search Alerts/Recalls
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