Catalog Number 382523 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/25/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.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 the bd insyte autoguard bc shielded iv catheter is not locking into the iv tubing and iv extension sets.Found during use.No reports of serious injury or medical intervention noted.
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Manufacturer Narrative
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Investigation summary: lot analysis review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples for adapter damaged/deformed/cracked and component damage were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Visual analysis: observations and testing: received one unused iag/bc 22ga unit in a sealed package from the representative lot number 8004515.Received one unused extension set in an opened package from icu medical.The actual unit was not returned for evaluation and testing.Visual/microscopic examination: no mechanical/physical damage was observed outside threads, or the inside rim of the luer adapter.Functional test: a functional assessment of the connection compatibility of the returned unit and extension was conducted to evaluate the reported incident.There was a successful connection between the returned catheter/adapter assembly with the returned ex-tube.Investigation conclusion: the defect adapter/connector defective/damaged, as stated as the reported code was not confirmed with the returned unit.Root cause: relationship of device to the reported incident: indeterminate.
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Search Alerts/Recalls
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