ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 12568 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been received for evaluation.Investigation is still pending.
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Event Description
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The event involved a clave¿ neutral connector where it was reported they are not staying on the ends of the intravenous (iv) catheters, causing them to leak.It was also reported there are issues running fluids by gravity on iv's that flush with no problems or obstructions.There was patient involvement, however no report of patient harm.
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Manufacturer Narrative
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One hundred and fifty-seven (157) new item list #12568 were returned for evaluation.As received, based on binomial stages sampling plan, thirty-five (35) samples were tested as per procedure and issues or anomalies were observed, the male luers also meet the iso product design specifications.No mating device was returned for evaluation.Complaint disconnection / loose connection cannot be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
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Search Alerts/Recalls
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