Model Number 1050052 |
Device Problem
No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.
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Event Description
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Country of complaint: (b)(6).Glue has no flow, tip was blocked.Facility reported multiple lot numbers with this issue.Three reports are filed: 2916714-2016-00727, 2916714-2016-00728, 2916714-2016-00729.
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Manufacturer Narrative
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Samples received: 50 unopened pouch.Analysis and results: there are no previous complaints of this code batch.(b)(4) units were manufactured and distributed in the market.There are no units in stock.Thirty-one (31) out of 45 samples evaluated were affected.There are polymerization nuclei along the cannula that caused the obstruction of the cannula.Ageing studies were performed with the purpose of provoking the complained defect and study the influence of environmental conditions in its apparition.-ampoules were stressed for 9 days at 40ºc and 30 % rh.After 4 days of exposure, the stress conditions caused the apparition of some polymerization nuclei along the cannula in the ampoules.However, the liquid glue could still pass through the cannula, that was not obstructed.After 9 days of exposure, the polymerization nuclei observed caused the obstruction of the cannula.The environmental conditions influence the apparition of the polymerization nuclei along the cannula.A temperature of 40ºc caused the formation of polymerization nuclei along the cannula and the obstruction of the cannula after 9 days of exposure.As instructed for use: histoacryl should be stored at ambient temperature below 22ºc.The ampoule containing the adhesive should only be removed from the aluminum pouch immediately prior to application.Final conclusion: taking into account that the samples received do not fulfill the oem specifications, it is concluded that the complaint is justified.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
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Search Alerts/Recalls
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