Thirteen jelco safety viavalve catheters were returned for analysis.The returned samples were visually evaluated and tested for seal leakage and for seal actuation per procedure and were found to be acceptable.As a result, the reported event could not be confirmed as a manufacturing-related nonconformance.In-process and at post sterile, product is evaluated for seal leakage and is inspected by certified operators using statistically valid sampling plans at defined intervals.If any nonconformances are found in process, the product is isolated, non-conformed and immediate action is taken to perform corrections.Sampling plans are based on random sampling selection and are designed to provide a high level of assurance that the true fraction defective is less than or equal to the established aql level for each quality characteristic.No correction or corrective actions will be conducted by the manufacturing facility at this time as there was no fault found.
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