The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The customer reported that the feeding set leaked at the base of the flush bag where the line to the patient starts.A patient was involved, but there was no patient injury, medical intervention, or adverse reaction associated with this event.
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