Catalog Number UNKNOWN |
Device Problems
Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Phlebitis (2004)
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Event Date 01/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a placeholder based on the reported phone area code.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that 21 unspecified bd nexiva¿ diffusics¿ closed iv catheter systems leaked, 6 caused localized iv site infections, and 79 had issues with infiltration/extravasation.The following information was provided by the initial reporter: "it was reported via post market survey that the clinician encountered occurrences of leakage (21), localised iv site infection (e.G.Cellulitis, abscess, phlebitis, thrombophlebitis) (6), infiltration / extravasation (79), and no / reduced flow of iv fluid (11)." "additional information related to localised iv site infection: "report of phlebitis by the pacu rns"".
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Manufacturer Narrative
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Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.A device history record review could not be performed because a model or lot number was not provided by the customer.
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Event Description
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It was reported that 21 unspecified bd nexiva¿ diffusics¿ closed iv catheter systems leaked, 6 caused localized iv site infections, and 79 had issues with infiltration/extravasation.The following information was provided by the initial reporter: "it was reported via post market survey that the clinician encountered occurrences of leakage (21), localised iv site infection (e.G.Cellulitis, abscess, phlebitis, thrombophlebitis) (6), infiltration / extravasation (79), and no / reduced flow of iv fluid (11)."."additional information related to localised iv site infection: "report of phlebitis by the pacu rns"".
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Search Alerts/Recalls
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