Catalog Number 383083 |
Device Problem
Material Perforation (2205)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/31/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd intima-ii¿ closed iv catheter system experienced the following information was provided by the initial reporter: the patient was given intravenous indwelling needle puncture for infusion therapy.The core of the indwelling needle did not match the hose (the core of the steel needle broke through the hose and the hose was not fed smoothly), resulting in children with ruptured blood vessels, the puncture was unsuccessful, to be re-punctured, and explain the communication work to the parents.
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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 the bd intima-ii¿ closed iv catheter system needle broke through the hose during use.The following information was provided by the initial reporter: the patient was given intravenous indwelling needle puncture for infusion therapy.The core of the indwelling needle did not match the hose (the core of the steel needle broke through the hose and the hose was not fed smoothly), resulting in children with ruptured blood vessels, the puncture was unsuccessful, to be re-punctured, and explain the communication work to the parents.
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Manufacturer Narrative
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The following field was updated due to corrections: b.5.Describe event or problem: it was reported that the bd intima-ii¿ closed iv catheter system needle broke through the hose during use.H.6.Investigation summary: in response to the event reported, a device history review was conducted for lot number 2110919.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.
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Search Alerts/Recalls
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