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Catalog Number 2C8537 |
Device Problems
Backflow (1064); Fluid/Blood Leak (1250); Failure to Disconnect (2541)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 an unspecified quantity of tubing of clearlink system continu-flo solution sets were breaking off into a non-baxter extension set.It was further stated that when disconnecting, the male luer breaks off into the female luer of the non-baxter extension set.This resulted in a fluid leak and blood backing up in the intravenous (iv) line.This issue was identified during patient infusion.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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D4: lot #: a suspect lot that was reported was r21d05048.H4: the manufacturing date of the suspect lot r21d05048 was 04/05/2021.H10: a batch review was conducted on the suspect lot and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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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