Catalog Number 381511 |
Device Problems
Material Deformation (2976); Suction Failure (4039)
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Patient Problem
Extravasation (1842)
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Event Date 03/28/2019 |
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 there was a difficult penetration due to poor catheter tip, as well as flashback with a bd insyte-n¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: it was reported that the bevel area of the catheter tip is bubbled.It was also reported that there is difficulty penetrating the skin, no or very little flashback, and veins are blowing.Uvc had to be placed which is more invasive and increased risk for infection.
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Event Description
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It was reported that there was a difficult penetration due to poor catheter tip, as well as flashback with a bd insyte-n¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter: it was reported that the bevel area of the catheter tip is bubbled.It was also reported that there is difficulty penetrating the skin, no or very little flashback, and veins are blowing.Uvc had to be placed which is more invasive and increased risk for infection.
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Manufacturer Narrative
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H.6.Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.
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Search Alerts/Recalls
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