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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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 first of three reports.
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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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Manufacturer Narrative
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The customer's complaint of the components not mating properly on item 011-a1000 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.
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Search Alerts/Recalls
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