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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Manufacturer Narrative
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He device is expected to be returned for evaluation, however, it it not yet received.Section e1 - phone number - (b)(6).
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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 complaint of broken on item 011-d1005 cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.Lot history review could not be performed due to lot number r16084 shared for this complaint doesn't exist, therefore the lot for this complaint is unknown.
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Search Alerts/Recalls
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