VitalFlow Set

Description of Event or Problem

Medtronic received information that prior to use of a Vital flow set, it was reported that on several occasions, customer noticed that the 50cc syringe inside the packaging for the syringe has been either poorly sealed or has been open. This has happened across multiple packs, and all other components in the Vital flow set have been fine. The damage is to the outer packaging. The device was not used. There was no patient involvement, so no adverse effect occurred.

Additional Manufacturer Narrative

Medtronic submits this report to comply with FDA regulations 21 CFR Parts 4 and 803. Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by FDA, Medtronic, or its employees that the device, Medtronic, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Medtronic will submit a supplemental report if additional relevant information becomes known.