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 08/11/2020 |
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.
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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 the sterile seal was breached prior to use.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
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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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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 the sterile seal was breached prior to use.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
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Search Alerts/Recalls
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