ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SURPLUG® MICRO CLEAR; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number IR-1S |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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One used surplug¿ micro clear was received for evaluation; no foreign matter was identified on the sample.A series of photographs were provided; the observed particulate can be confirmed, however the source of the particle is unknown.The device history review could not be conducted because no lot number(s) was/were identified.
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Event Description
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The event involved a surplug micro clear that was reported to be broken.The reporter stated that when the user opened the individual package at the hospital ward, he/she noticed that the valve was recessed.It was further reported that the valve edge was fixed and partial gap was confirmed.The internal conduit tip was said to be exposed and visible.Around the conduit exposed portion, valve tearing was observed/confirmed by the customer.No scratches or damages were observed in the housing.Red foreign substance was identified on the inner surface of tip part.The customer reported that upon checking the blood reaction, the result shows positive the device was changed out/replaced with no further problems encountered.The event occurred during patient use; however, no harm was reported as a consequence of this event.
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Search Alerts/Recalls
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