ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 011-D1005 |
Device Problem
Disconnection (1171)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/01/2023 |
Event Type
malfunction
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Event Description
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The event occurred on an unspecified date and involved a tego® connector which was reported to have had an unspecified problem.The reporter stated that the unspecified condition could lead to life-threatening bleeding.The customer stated that there was patient involvement, and unknown harm.Additional information was received on 14 november, 2023, and the customer stated there was a case where a patient was on dialysis, and there was a disconnection with tego connector and permcathcatheter.This new model of tego plug detached, causing relevant acute hemorrhage and relevant hemoglobin being effected due to hemorrhage.No information was provided as to whether or not medical intervention was necessary.
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Manufacturer Narrative
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The device is expected to be returned for evaluation, however, it it not yet received.Section e1 - phone number - (b)(6).
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Manufacturer Narrative
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No product samples, videos, or photographs were provided for investigation.No dhr lot review was conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.Lot history review was conducted because no lot number(s) was/were identified.Additional information d9 section.
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Search Alerts/Recalls
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