Catalog Number 381433 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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It was reported that bd insyte autoguard needle did not retract.Yyyyy the following information was provided by the initial reporter: description as reported: per customer, " we have had a couple of safety alerts come through the last two days from xxx, yyyy, and zzzz regarding bd insyte catheters.The reports we have received have been incidents where the needle has failed to retract.No patient was harmed in the incidents.
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Manufacturer Narrative
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Investigation results: a device history record review was completed by our quality engineer team for provided material number 381433 and lot number 3268835.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Sfurther action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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