Catalog Number K12-MZT3301A |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/14/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The affected device has not yet 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 distributor reported a defect in the packaging.This was identified during their initial inspection of received product.The device was not sent to a user facility.
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Manufacturer Narrative
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Device evaluation: one device was returned for evaluation.The device was visually inspected and a breach in the sterile barrier was observed.The complaint is confirmed.The root cause is attributed to rough handling.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.
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Search Alerts/Recalls
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