Catalog Number 400714 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that 14 anesthesia kit durasafe 18 x 3-1/2 were damaged, but still operable.The following information was provided by the initial reporter: "inner damage".
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Manufacturer Narrative
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H.6.Investigation: a device history record review was performed for provided lot number 0125707 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, four picture samples were returned for evaluation by our quality engineer team.However, the reported "inner damage" could not be identified through examination of the picture samples.Based on the investigation results, the complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.
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Event Description
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It was reported that 14 anesthesia kit durasafe 18x3-1/2 were damaged, but still operable.The following information was provided by the initial reporter: "inner damage.".
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Search Alerts/Recalls
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