C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 15CM (STRAIGHT) (ST) (DL); CATHETER, HEMODIALYSIS, NON-IMPLANTED
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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Alteration in Body Temperature (4568)
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Event Date 07/03/2023 |
Event Type
Injury
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Event Description
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It was reported on (b)(6) 2023, due to chronic kidney disease stage 5 patient was admitted to the renal department, temporary catheterization of right internal jugular vein was performed on the same day.On (b)(6) 2023, left forearm arteriovenous fistula.On (b)(6) 2023, the hemodialysis process was smooth, the general condition was ok, patient was discharged from the department, transferred for regular hemodialysis (through the right internal jugular vein temporary tube).At the end of june, fever appeared shortly after hemodialysis, and she was hospitalized and reported anti-infection treatment.The specific course of treatment is unknown.On (b)(6) 2023, due to poor anti-infection treatment, she was hospitalized in eicu.On the day of admission, the right internal jugular vein catheter was removed and the right femoral vein temporary catheter (arrow) was placed.On (b)(6) 2032, transferred to renal department for further treatment.
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Manufacturer Narrative
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H11: section a through f - 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.
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Manufacturer Narrative
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H11: section a through f - 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.
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Event Description
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It was reported on (b)(6) 2023, due to chronic kidney disease stage 5 patient was admitted to the renal department, temporary catheterization of right internal jugular vein was performed on the same day.On (b)(6) 2023, left forearm arteriovenous fistula.On (b)(6) 2023, the hemodialysis process was smooth, the general condition was ok, patient was discharged from the department, transferred for regular hemodialysis (through the right internal jugular vein temporary tube).At the end of june, fever appeared shortly after hemodialysis, and she was hospitalized and reported anti-infection treatment.The specific course of treatment is unknown.On (b)(6) 2023, due to poor anti-infection treatment, she was hospitalized in eicu.On the day of admission, the right internal jugular vein catheter was removed and the right femoral vein temporary catheter (arrow) was placed.On 07.10, transferred to renal department for further treatment.Additional information received 8/30/2023: it was reported the patient did not have any other signs of infection other than a fever.No blood cultures were drawn.Fever did not resolve after the dialysis catheter was removed.
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