A visual inspection confirmed the presence of fluid inside the packaging of the returned device.It was suspected that the fluid was silicone.Devices were sampled and sent for infra-red spectrophotometer (ir) testing.The results confirmed that the substance was silicone which had migrated inside the packaging of the device during storage.Silicone is used as a lubricant during the manufacturing process and has been determined to be biocompatible.Devices with silicone found in the packaging can continue to be used and pose no risk to the patient.The event has been confirmed, there was no malfunction of the reported devices.(b)(4).
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