Catalog Number K12-MS2666A |
Device Problems
Delivered as Unsterile Product (1421); Device Packaging Compromised (2916)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/13/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation: one device has been returned for evaluation.The evaluation is in process.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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One device was returned for evaluation.Unfortunately, the device cannot be located.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 can no longer be found, the root cause could not be determined.If the device is located in the future this investigation will be reopened and a follow up submitted.
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Search Alerts/Recalls
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