Model Number 381423 |
Device Problem
Retraction Problem (1536)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 01/19/2023 |
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.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¿ shielded iv catheter needle failed to retract when the button was pressed, resulting in a dirty needle stick.No further information was provided.The following information was provided by the initial reporter: "we have had some issues with 22g autoguards.Our end users are saying the button is not working and this has resulted in at least 1 needle stick.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 03-mar-2023.Investigation summary: our quality engineer inspected the sample submitted for evaluation.Bd received one used and retracted 22g x 1.00in.Insyte autoguard needle assembly from lot number 2284590.A gross visual inspection of the returned unit did not identify any damage or defects to the components.The unit was un-retracted and then tested for retraction.The unit successfully retracted without issue.Further inspection was performed microscopically to check for any evidence that could have previously prevented retraction in the user environment.There was no adhesive or other damage/defects could be identified.The returned unit provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failure stated in your report.A device history record review showed no non-conformances associated with this issue during the production of this batch.However, a trend has been identified for the reported failure and corrective actions have been initiated to investigate this type of incident and identity the root cause.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter needle failed to retract when the button was pressed, resulting in a dirty needle stick.No further information was provided.The following information was provided by the initial reporter: "we have had some issues with 22g autoguards.Our end users are saying the button is not working and this has resulted in at least 1 needle stick.".
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Search Alerts/Recalls
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