ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NANOCLAVE® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 011-A1000 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device is available to be returned for evaluation; however, it has not yet been received.
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Event Description
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The complaint/event involved a nanoclave® connector.It was reported that the slip syringes popped off of the nanoclave when they were attached using the correct technique during a patient infusion of an unspecified drug/medication.There was no blood loss, no unprotected chemo exposure, no adverse operator consequences and no medical/surgical intervention required.The device was changed out/replaced with no further problems encountered.The patient reportedly returned to baseline condition.There was no serious injury/death, however there was a delay in the unspecified therapy.This is the second of three reports.
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Manufacturer Narrative
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The customer's complaint of the components not mating properly on item (b)(4) cannot be confirmed by investigation.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.The device history record could not be reviewed due to the unknown lot number.Updated information can be found in d9.
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Search Alerts/Recalls
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