C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Hematoma (1884)
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Event Date 06/16/2022 |
Event Type
Injury
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Event Description
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It was reported that when the catheter was paused, under ultrasound, the doctor had difficulty introducing the catheter into the jugular despite correct dilation.He used another catheter from the same lot, the patient has a jugular hematoma.Both devices were discarded after event.Additional information received 7/11/22: it was reported by healthcare professional ¿the hematoma occurred when the kit was attempted despite placement under echo and optimal dilation with, i think, a kit that had to go partly subcutaneously.So the hematoma is consecutive to the installation of the kit and prevented the installation of another kit in the same place.It was reported this occurred with two devices.This report addresses the second device.
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Manufacturer Narrative
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The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refx3191 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in france.
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Search Alerts/Recalls
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