Catalog Number 383517 |
Device Problems
Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with sterility.It was stated ¿the package has black stripes and the item was not sealed properly.¿ there was no report of injury or further medical intervention.
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Event Description
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It was reported with the use of the bd nexiva¿ closed iv catheter system there was an issue with sterility.It was stated ¿the package has black stripes and the item was not sealed properly.¿ there was no report of injury or further medical intervention.
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Manufacturer Narrative
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Investigation summary: two unused units were returned from the customer in support of this complaint.The reported defect was observed.Dhr review - no related issues were identified during the production of the batch.Eura review - the presence of splice tape on the packaging was identified as a risk.The occurrence of this incident does not exceed what is considered acceptable.Investigation conclusion: the cause of the defect was splice tape on the product.The cause of splice tape making it through the inspections in the process is indeterminate.
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Search Alerts/Recalls
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