Catalog Number ND02-025/08 C |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device is available for return.A follow up report will be filed once the quality investigation is complete.
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Event Description
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It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.
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Manufacturer Narrative
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The reported product involved with this event was returned for evaluation.On receipt of the product the product blister pack was observed to be open.The packaging development engineer concluded that the root cause for the open pack was undetermined.The cause of the disintegrated/fragmented product was as a result of the open blister pack.A device history record (dhr) review and retained sample testing of the packaging of this lot number was performed and all manufacturing specifications were met during the time of manufacture of this product.Nasopore product ifu contains the note; "do not use if the package is open or damaged.".
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Event Description
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It was reported that there was a potential sterility breach on the packaging of the device.It was also reported that it was noticed prior to the procedure.It was further reported that there was no delay or adverse consequences as a result of this event.
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Search Alerts/Recalls
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