ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® (GREEN, GLOW RINGS), 2 0.2 MICRON; STOPCOCK, I.V. SET
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Model Number B33199 |
Device Problems
Particulates (1451); Microbial Contamination of Device (2303)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been requested for evaluation.However, it has not yet been received.
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Event Description
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The event involved a 7" (18 cm) smallbore trifuse ext set w/3 microclave® 2 rings (green, glow), 2-0.2 micron filters, 3 clamps, rotating luer on an unknown date.It was reported that there was mold inside the filtration piece of the device.The event happened on two occasions.There was unknown patient involvement and unknown human harm or adverse event.This is the second of two events.
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Manufacturer Narrative
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The complaint of particulate on the b33199 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) could not be performed due to the unknown lot number.D9: sample availability updated to "no" as sample was not returned.
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Search Alerts/Recalls
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