C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 15CM STRAIGHT SHORT-TERM DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED
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Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 07/21/2023 |
Event Type
Injury
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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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Event Description
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It was reported that on "06.08, due to chronic kidney disease stage 5 admitted to the renal department, temporary catheterization of right internal jugular vein was performed on the same day.On 06.14, left forearm arteriovenous fistula.06.19, the hemodialysis process was smooth, the general condition was ok, patient was discharged from the department, transferred to facility regular hemodialysis (through the right internal jugular vein temporary tube).07.03, patient was hospitalized in eicu of our hospital.On the day of admission, the right internal jugular vein catheter was removed and the right femoral vein temporary catheter was placed.07.10, transferred to renal department for further treatment.07.13, pulmonary artery ct examination showed no foreign body.07.14, right femoral vein catheterization was removed and right internal jugular vein temporary catheterization was performed in renal department.07.21, pulmonary ct examination showed a dense shadow in the right lower pulmonary artery.07.26: pulmonary angiography and foreign body removal under dsa were to be performed.Due to non-development, the foreign body could not be removed.The specific foreign body condition was unknown.".
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Event Description
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It was reported that on "(b)(6) due to chronic kidney disease stage 5 admitted to the renal department, temporary catheterization of right internal jugular vein was performed on the same day.On (b)(6) , left forearm arteriovenous fistula.(b)(6) the hemodialysis process was smooth, the general condition was ok, patient was discharged from the department, transferred to facility regular hemodialysis (through the right internal jugular vein temporary tube).(b)(6) , patient was hospitalized in eicu of our hospital.On the day of admission, the right internal jugular vein catheter was removed and the right femoral vein temporary catheter was placed.(b)(6), transferred to renal department for further treatment.(b)(6), pulmonary artery ct examination showed no foreign body.(b)(6) , right femoral vein catheterization was removed and right internal jugular vein temporary catheterization was performed in renal department.(b)(6), pulmonary ct examination showed a dense shadow in the right lower pulmonary artery.(b)(6): pulmonary angiography and foreign body removal under dsa were to be performed.Due to non-development, the foreign body could not be removed.The specific foreign body condition was unknown." additional information received (b)(6) 2023: it was reported that the patient status is good but foreign body still not be removed.The foreign body is suspected to be from the catheter but it is not confirmed.
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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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