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 04/02/2019 |
Event Type
Injury
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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 increase for infection.
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Manufacturer Narrative
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Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.
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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 increase for infection.
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Search Alerts/Recalls
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