Model Number 386801 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/21/2021 |
Event Type
Injury
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Event Description
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It was reported while using bd cathena safety iv catheter with bd multiguard technology blood could not be drawn from the catheter.The following information was provided by the initial reporter: what was the level of harm?: harm or clinically serious adverse event multiple peripheral iv's in place each iv catheter was a style that reduces backflow of blood with small white stoppers in the hub.Were unable to draw a vbg either by venipuncture (physiology of pt) or from iv catheter sites.The patient had a clinical deterioration of which we could not monitor point of care blood work.Who was affected? patient.
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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 while using bd cathena safety iv catheter with bd multiguard technology blood could not be drawn from the catheter.The following information was provided by the initial reporter: what was the level of harm?: harm or clinically serious adverse event.Multiple peripheral iv's in place each iv catheter was a style that reduces backflow of blood with small white stoppers in the hub.Were unable to draw a vbg either by venipuncture (physiology of pt) or from iv catheter sites.The patient had a clinical deterioration of which we could not monitor point of care blood work.Who was affected? patient.
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Manufacturer Narrative
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H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.H3 other text : see h.10.
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Search Alerts/Recalls
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