ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO¿ CONNECTOR; SET, INTRAVASCULAR, ADMINISTRATION
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Catalog Number D1000 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation, however, it has not yet been received.E1 - (b)(4).
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Event Description
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The event involved a atego® connector where the customer reported a tear at the slit of the silicone sleeve".The event occurred during a dialysis treatment.There was patient involvement, but harm was not reported as a consequence of this event.
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Manufacturer Narrative
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No product samples, videos, or photographs were provided for investigation.A probable cause cannot be identified based on the information that has been provided.Lot history review could not be conducted because no lot number(s) was/were identified.
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Search Alerts/Recalls
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