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 10/11/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone number: (b)(6); initial reporter fax number: (b)(6).Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformance's 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 bd saf-t-intima¿ safety system with removable prn had foreign matter in the device cannula.The following information was provided by the initial reporter: "after opening the indwelling needle, it was found that there was a milky unidentified substance in the needle, so it could not be used.The trocar was replaced immediately and the puncture was continued without adverse consequences.".
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Manufacturer Narrative
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Initial reporter phone number: (b)(6); initial reporter fax number: (b)(6).Investigation summary: since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.Examination of the product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformance's 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 bd saf-t-intima¿ safety system with removable prn had foreign matter in the device cannula.The following information was provided by the initial reporter: "after opening the indwelling needle, it was found that there was a milky unidentified substance in the needle, so it could not be used.The trocar was replaced immediately and the puncture was continued without adverse consequences.".
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Search Alerts/Recalls
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