H3: 81 other ¿ at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Device evaluation: g3, g6, h2, h3, h6 and h10.Result of investigation: the quality personnel from molding area conducted a dimensional inspection of cap part number 65-1376d.This inspection revealed that all samples met the specified specifications.Furthermore, quality personnel from the incoming area conducted a dimensional inspection of connector part number 65-1481 on all physical samples and all samples were found to be within specifications.As a result, the reported defect was not confirmed.Based on the above, the reported defect was not confirmed and root cause not established.
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