Catalog Number 381923 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd insyte¿ autoguard¿ winged shielded iv catheter 22ga 1.00in there was a connection issue resulting in air in the line.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this report is about connection failure.When blood was collected with a syringe, air came in.
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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This report is about connection failure.When blood was collected with a syringe, air came in.
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Manufacturer Narrative
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Investigation results: our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one used 22g x 1.00in.Insyte autoguard winged unit from lot number 2290794.Additionally, five photos were provided for investigation.The photos are representative of what was returned and do not provide any additional evidence that isn¿t already covered by the physical sample evaluation.A gross visual inspection of the returned unit did not identify any damage to the components.The unit was tested for leakage where a leak was identified originating from the luer hub.Further inspection under a microscope found that a portion of the inside wall of the catheter adapter near the luer hub was sheared.The unit was functionally tested for aspiration and air was noted to be pulled in during aspiration.The reported issue was confirmed and determined to be manufacturing related as the adapter/connector of the device was found damaged.Damage to the luer may occur due to misalignment between the adapter and manufacturing equipment resulting in excess force to the wall of the adapter.Operators perform sampling per the quality plan to detect and mitigate the occurrence of this defect.Additionally, preventative maintenance (pm) is performed to ensure proper functioning of the manufacturing equipment.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
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Search Alerts/Recalls
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