Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Phlebitis (2004)
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Event Date 09/21/2021 |
Event Type
Death
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that unspecified bd¿ venflon pro was used and the patient died of an unknown cause.The following information was provided by the initial reporter: it was reported via post market survey that clinicians encountered phlebitis (2), extravasation (not related to high pressure injection of contrast media) (12), extravasation with high pressure injection of contrast media (1) and cannula occlusion (10).One potion of the excel sheet states: therapy was then suspended as patient deceased.
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Event Description
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It was reported that unspecified bd¿ venflon pro was used and the patient died of an unknown cause.The following information was provided by the initial reporter: it was reported via post market survey that clinicians encountered phlebitis (2), extravasation (not related to high pressure injection of contrast media) (12), extravasation with high pressure injection of contrast media (1) and cannula occlusion (10).One potion of the excel sheet states: therapy was then suspended as patient deceased.
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Manufacturer Narrative
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Correction: the patient death is not suspected to have been caused or not contributed to by the bd device.No other adverse event were reported.This complaint is not mdr reportable.
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Search Alerts/Recalls
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