Catalog Number ND02-025/08 C |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
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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 noted that there was moisture in the pack during visual inspection prior to use.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.
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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 noted that there was moisture in the pack during visual inspection prior to use.It was also reported that there was no adverse consequences and no delays as a result of this event and the procedure was completed successfully.
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Manufacturer Narrative
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H6; the nasopore product and packaging reported involved in this event was returned for evaluation.On receipt of the product and packaging the reported malfunction of an open(compromised) package seal was confirmed.The product and packaging was evaluated by the product packaging engineer who concluded that the packaging seal is open at one end of the package (approx.25% open) (chevron end).Seal integrity has been breached.There is evidence of seal transfer are there in the blister and tyvek.There is no obvious damage to the device or blister package.The seal transfer indicates that the package was sealed at some point.The amount of seal transfer indicates that there was likely to have been a good seal in place at time of manufacture.The root cause of this event is undetermined.
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Search Alerts/Recalls
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