Model Number 381534 |
Device Problem
Contamination (1120)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/23/2022 |
Event Type
malfunction
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Event Description
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It was reported while using bd insyte autoguard winged, 20g x 1.16" foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: black speckles on the cather.
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H6: investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.
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Event Description
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It was reported while using bd insyte autoguard winged, 20g x 1.16" foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: black speckles on the cather.
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Search Alerts/Recalls
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