Catalog Number 2C2117K |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that the blue winged luer cap of a small volume intermate fell off.This issue was discovered before patient use.There was no patient involvement.No additional information was available.
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photo observed that the blue winged luer cap separated from the distal luer lock.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H11: the actual device was received for evaluation.A visual inspection was performed, and the device did not have any separated, loose, or missing caps or components.All components from the sample were present and securely attached to the device.No evidence of defect was found in the sample.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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