Catalog Number 383552 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that there were 16 bd closed iv catheter nexiva¿ where the print on individual packaging is missing.The following information was provided by the initial reporter: it was reported that 16 of 20 are missing the printed information on the individual packaging of each catheter.
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the photos submitted for evaluation.Bd received two photos.During the visual examination of the photos, it was observed that print was missing from (b)(4) units confirming your reported issue.When a new roll of top web is replaced, missing print can occur.These units are automatically rejected but still have the potential to be hand packed when an operator sorts through the rejected parts.Missing print can also occur due to printer failure or a software issue.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
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Event Description
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It was reported that there were 16 bd closed iv catheter nexiva¿ where the print on individual packaging is missing.The following information was provided by the initial reporter: it was reported that 16 of 20 are missing the printed information on the individual packaging of each catheter.
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Search Alerts/Recalls
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