ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM)APPX 15.3ML 20 DROP ADMIN W/MICROCLAVE®, 0.2 MICRON FILTER, FLOW CO; STOPCOCK, I.V. SET
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Model Number B9837 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is pending investigation.
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Event Description
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The customer reported that a 102" (259 cm)appx 15.3ml 20 drop admin w/microclave®, 0.2 micron filter, flow controller, rotating luer was defective.It was further described that the dial-a-flow isn¿t working correctly and the flow rate is too fast.There was patient involvement but there was no harm or delay in therapy.
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Manufacturer Narrative
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One used 102" (259 cm)appx 15.3ml 20 drop admin w/microclave¿, 0.2 micron filter, flow controller, rotating luer was received and visually inspected.As received, no visible damage or anomalies were observed.No mating devices were returned.The set was primed while the flow regulator was in the open position.Unrestricted flow was established.A flow controller test was conducted and the product met performance specifications.The reported complaint could not be confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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Search Alerts/Recalls
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