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Catalog Number 1C8109 |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2024 |
Event Type
malfunction
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Manufacturer Narrative
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G1: device manufacturer address 1: (b)(6).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 a solution set leaked during patient infusion.After the nurse hung the medication, the tubing detached from the plastic collar and leaked.The medication leaked all over the floor and the patient.Prompt cleanup occurred.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, a photograph of the sample was provided for evaluation.From the photo, it was observed that the tubing was disconnected from the male luer.The reported condition was verified.The cause of the condition could not be determined; however, the probable cause was a manufacturing issue.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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