Model Number 383312 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2021 |
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 the bd saf-t-intima¿ iv catheter safety system experienced foreign matter in the device cannula.The following information was provided by the initial reporter: there is a black foreign matter at the indwelling needle.
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Manufacturer Narrative
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H6: investigation summary- since no photos or 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd saf-t-intima¿ iv catheter safety system experienced foreign matter in the device cannula.The following information was provided by the initial reporter: there is a black foreign matter at the indwelling needle.
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Search Alerts/Recalls
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