ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number D1000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation, however, it is yet to be returned.
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Event Description
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The device involved a tego¿ connector that leaked during patient use.The customer reported that when removing the lines, the transparent material of the tego stopper pulled back slightly causing leakage of blood (less than 20ml approximately) from the limbs of the catheter.The device was in place since (b)(6), 2021.There was patient involvement, however, there was no patient injury associated with this event.The patient recovered and there was no medical intervention associated with this incident.This is report 2 of 2.
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Manufacturer Narrative
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Two d1000 tego connectors were returned.The was no visual damage or anomalies with either of the two d1000 tego connector assemblies.No mating devices were returned to evaluate with the two d1000 tego connectors.Subsequent pressure and vacuum leak testing showed the two d1000 tego connectors to meet pressure and vacuum leak expectations outlined in the product performance specification.The complaint of leakage could not be replicated or confirmed.A device history review of lot# 4968052 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
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Search Alerts/Recalls
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