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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Correction to h6: type of investigation (replace b17 with b15).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H4: the device was manufactured from march 28, 2023 to march 29, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph 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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Search Alerts/Recalls
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