Catalog Number K09-09657AP |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/07/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The affected device has not been returned for evaluation.A follow up report will be submitted when the evaluation has been completed.
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Event Description
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The user reported that air was pulled into the syringe through the contrast tubing.The air was cleared from the system.No air was injected into the patient.No harm or injury to the patient was reported.
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Manufacturer Narrative
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No device is expected to be returned for investigation.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints for this lot number were found.Because the unit was not returned, the root cause could not be determined.If the device is returned in the future this investigation will be reopened and a follow up submitted.
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Search Alerts/Recalls
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