Catalog Number 2C2063K |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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The device has been received, and the evaluation is in progress.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 "upper beak" of eight (8) large volume infusors were broken; further described as detached.This was observed prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: eight (8) actual devices were received for evaluation.A visual inspection was performed using the naked eye found the housing was malformed which caused the purple coil cap to detach from the housing.The reported condition of damaged was verified.The cause of the condition was due to extreme heat temperature during shipping.A nonconformance has been opened to address this issue.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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