MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 15CM STRAIGHT SHORT-TERM DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.".
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 15CM STRAIGHT SHORT-TERM DL
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17638570
• Report Number: 3006260740-2023-03722
• Device Sequence Number: 7936315
• Product Code: MPB
• UDI-Device Identifier: 00801741045356
• UDI-Public: (01)00801741045356
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 5553150
• Device Lot Number: REGQ3802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown