BAXTER HEALTHCARE CORPORATION ONE-LINK NEUTRAL LUER ACTIVATED DEVICE; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 7N8399 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
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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 a one-link needle-free iv connector was leaking contrast from between the connection of the clave hub and the catheter/needle hub.This issue was further described as, ¿baxter claves will actually ¿crack¿ if turned too tight, or if you actually turn past the junction, it remains loose¿.The leak was observed while injecting contrast at 3.0-5.0 flow rate.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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Event date ¿ this issue occurred on an unspecified date during the week of march 8th should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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