G1: manufacturer site address - (b)(6).Device evaluated by manufacturer: returned product consisted of the 6f impulse diagnostic catheter inside the sealed product pouch.A photo was also reviewed for analysis.The photo was reviewed for the reported packaging contamination.The photo is of the distal end of the curved shaft and tip with the plastic sleeve and securement label.As it was reported that the issue was in the photo, it is correct to assume that the plastic sleeve and the securement label is what the facility is referring to.The packaging, hub, shaft, and tip were visually examined.Inspection of the device revealed that the device was received in the sealed product pouch on the product card.The device was inspected through the product pouch and there was no fm present.The only things in the sealed product pouch were the product card, the device, the plastic sleeve and a securement label.All these things are supposed to be in the sealed pouch per the manufactured procedure.It was confirmed through the attached photo in the complaint record, that the protective sleeve and securement label is to help maintain the curve during transport and is to be included per process.Product analysis did not confirm the reported event, as there was no fm/packaging contamination.
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