Model Number 384539 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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Picc was inserted into the baby.Then it was discovered that the y-connector could not be removed from the picc hub.Picc had to be removed from the baby and a new line had to be inserted.
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Manufacturer Narrative
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The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
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Event Description
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Picc was inserted into the baby.Then it was discovered that the y-connector could not be removed from the picc hub.Picc had to be removed from the baby and a new line had to be inserted.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.One catheter was returned for review.Visual inspection found signs of use.An attempt to remove the y site connection from the hub confirmed the issue reported by the customer but after using extreme force, the connection was removed from the hub.Most likely the components were overtightened.A definite root cause for this issue could not be determined with confidence.It could not be determined if the y site connection was overtightened during assembly, packaging, or in the user environment.Since a definite root cause could not be established, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.
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Event Description
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Picc was inserted into the baby.Then it was discovered that the y-connector could not be removed from the picc hub.Picc had to be removed from the baby and a new line had to be inserted.
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Search Alerts/Recalls
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