ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 20" (51 CM) APPX 0.60 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, LUER LOCK; STOPCOCK, I.V. SET
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Catalog Number MC330279 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
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Event Description
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The event involved a 20" (51 cm) appx 0.60 ml, smallbore ext set w/microclave® clear, luer lock, where it was reported there is a defect that causes air to become trapped in the connector itself, releasing air into the central line.Our client was hospitalized 3 times including once where the central line needed to be replaced.There was patient involvement and there was patient harm.This captures 1 out of 3 occurrences.
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Manufacturer Narrative
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Received three new.List #mc330279, 20" (51 cm) appx 0.60 ml, smallbore ext set w/microclave® clear, luer lock; lot #4799947.The new sets received passed all functional tests and no leaks were observed, and no air was found in line during use.Without the return of the used set, the reported complaint could not be confirmed.A device history review (dhr) lot # review was conducted, no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to manufacturer on 10/2/2023.
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Search Alerts/Recalls
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