Catalog Number 383593 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/14/2019 |
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 that during use the needle went through the catheter with a bd nexiva diffusics 20g x 1.00 in.The following information was provided by the initial reporter: the plastic over the needle has partially pulled apart from the needle.
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Manufacturer Narrative
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Investigation: a device history review was conducted for lot number 9056970.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
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Event Description
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It was reported that during use the needle went through the catheter with a bd nexiva diffusics 20g x 1.00 in.The following information was provided by the initial reporter: the plastic over the needle has partially pulled apart from the needle.
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Search Alerts/Recalls
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