Model Number 381212 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 05/16/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd insyte¿, peripheral iv cannula, bd vialon¿ needle pierces the catheter.The following information was provided by the initial reporter: "the problem occurs when the needle is inserted into the catheter.The needle pierces the catheter and when the catheter comes out it is split.This also causes the patient's vein to burst.This problem has happened to several different patients (at least 3 patients) and the nurses have assured me that this is a regular problem.¿.
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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 and/or device history review, a supplemental report will be filed.
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Manufacturer Narrative
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Investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
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Event Description
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It was reported that the bd insyte¿, peripheral iv cannula, bd vialon¿ needle pierces the catheter.The following information was provided by the initial reporter: "the problem occurs when the needle is inserted into the catheter.The needle pierces the catheter and when the catheter comes out it is split.This also causes the patient's vein to burst.This problem has happened to several different patients (at least 3 patients) and the nurses have assured me that this is a regular problem.¿.
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Search Alerts/Recalls
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