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Model Number MZ1000 |
Device Problems
Backflow (1064); Obstruction of Flow (2423)
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Patient Problem
Extravasation (1842)
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Event Date 04/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is mz1000-07.The 510k number provided in section g5 is for the domestic similar product.Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the logs/device be received for evaluation.
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Event Description
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The reported feedback suggests that the device with extravasation of medication, serum at the insertion.From the reported information, the extent of patient injury as result of the extravasation has not been clarified.
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Search Alerts/Recalls
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