BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2C8541 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/24/2023 |
Event Type
malfunction
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Event Description
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It was reported that a clearlink system continu-flo solution set had a defect.This was discovered during patient use.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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G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information was added to h3, h6, and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed and a crack at the luer lock body was observed.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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