Catalog Number 0684-00-0567 |
Device Problems
Contamination of Device Ingredient or Reagent (2901); Device Packaging Compromised (2916)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.We continue our efforts to follow up for its return.(b)(4).
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Event Description
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It was reported that 50 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside.The packaging is reported to be intact.This was reported by a distributor in (b)(4).This product was not shipped to the end user and therefore there was no patient involvement.This mdr is for 23 of 50 of the devices.
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Manufacturer Narrative
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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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Event Description
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It was reported that 50 devices of this batch have fluid visible between the tray and tray cover with no sign of fluid contamination from the outside.The packaging is reported to be intact.This was reported by a distributor in (b)(6).This product was not shipped to the end user and therefore there was no patient involvement.This mdr is for 23 of 50 of the devices.
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Search Alerts/Recalls
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