Catalog Number 2C6227 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Lot #: the lot reported is r20e18114.Initial reporter address: (b)(6).Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the tubing of the extension set "burst" when injected with contrast.The set was connected to the power injector syringe.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph which observed that the tubing was burst.The reported condition was verified.The cause of the condition was unable to be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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