Catalog Number 2C8750 |
Device Problem
Connection Problem (2900)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Date of event: (b)(6) 2017.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the port that connects to the patient¿s iv line ¿was not working so the tubing could not be attached to the patient¿.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was received for evaluation.Functional testing was performed and the luer activated valve failed to engage the luer locking mechanism.The reported condition was verified.The definitive cause of the reported 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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