ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 118" (300 CM) APPX 9.3 ML, TRANSFER SET W/ANTI-SIPHON VALVE, 3-WAY STOPCOCK, 2 M; STOPCOCK. I.V. SET
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Model Number B33381 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer indicated that the device is not available for investigation.
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Event Description
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The event occurred on an unknown day in (b)(6) 2019.The clave on the prepared tubing was not secure and trained air into line.There was patient involvement, however, there was no adverse event.This report captures the third of 4 incidents.
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Manufacturer Narrative
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No product samples, videos, or photographs were returned for investigation.The dhr was reviewed and there were no 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.The dhr for lot 3587835 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.
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Search Alerts/Recalls
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