ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.31 ML, SMALLBORE EXT SET W/REMV MICROCLAVE CLEAR, NANOCLAVE T; STOPCOCK, I.V. SET
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Model Number A1009 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
Blood Loss (2597)
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Event Date 02/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer indicated that the device is not available for investigation.Without the returned device, a comprehensive failure investigation cannot be performed.If additional information is received, and supplemental report will be submitted.
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Event Description
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The event involved a smallbore extension set with a crack in the extension tubing where it has two wings.When the vacutainer is twisted on the blood starts leaking significantly no matter how much it is tightened.There was a patient involved, however, there was no injury as result of this event.This report captures the first of 3 incidents.
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Manufacturer Narrative
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H10: no product samples, videos, or photographs were returned for investigation.The dhr (device history review) for lot number 4536601 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.
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Search Alerts/Recalls
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