Catalog Number 234-020-280 |
Device Problem
Shelf Life Exceeded (1567)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.(b)(4).
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Event Description
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It was reported that an expired product was used.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: expired lot used.Probable root cause: design: insufficient labeling design, insufficient shelf life validated.Application: use past device/packaging shelf life.Gtin: (b)(4).
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Event Description
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It was reported that an expired product was used.
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Search Alerts/Recalls
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