BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number AMC9668 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/16/2023 |
Event Type
malfunction
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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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Event Description
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It was reported that the collar around the male luer lock of continu-flo solution set separated and was missing.This issue was further described as, ¿the adapter did not have a luer lock thread and the equipment could not be connected to a three-way stopcock or catheter¿.This issue was observed during medication administration to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information was added to d9, h3, h4, h6 and h10.H4: device manufactured in march 2023.H10: the device was received for evaluation.A visual inspection was done which observed a missing luer lock.The reported condition was verified.The cause of the condition was due to 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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