MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM PRE-CURVED SHORT-TERM DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported that, "on monday, (b)(6), the placement of a 15cm, 13.5 fr niagara catheter is scheduled for insertion.At the time of puncture, it is observed that there is no hermetic seal between the needle and the syringe because adequate suction is not observed after the puncture, which it is necessary to obtain venous return from the vessel to which one wishes to access, when aspirating the solution and pressing the plunger, a leak is observed between it, it is decided to use another new 20 cm catheter, 13.5 fr, however, the same situation occurs, different syringes are used both 5cc and 10cc sterile without obtaining adequate functionality, so the procedure is suspended." additional information received on may 18, 2023: the patient could not receive his treatment, due to the problem presented.This report addresses the first insertion attempt with a15 cm catheter.
Event or Problem Description
It was reported that, "on monday, (b)(6), the placement of a 15cm, 13.5 fr niagara catheter is scheduled for insertion.At the time of puncture, it is observed that there is no hermetic seal between the needle and the syringe because adequate suction is not observed after the puncture, which it is necessary to obtain venous return from the vessel to which one wishes to access, when aspirating the solution and pressing the plunger, a leak is observed between it, it is decided to use another new 20 cm catheter, 13.5 fr, however, the same situation occurs, different syringes are used both 5cc and 10cc sterile without obtaining adequate functionality, so the procedure is suspended." additional information received on may 18, 2023: the patient could not receive his treatment, due to the problem presented.This report addresses the first insertion attempt with a15 cm catheter.
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 complaint of unable to aspirate is confirmed but the exact cause remains unknown.One video sample of an 18 ga introducer needle attached to a syringe was provided for evaluation.The user is attempting to aspirate fluid within a bowl; however, no liquid is found to aspirate.When fluid is infused through the needle, the fluid is found to leak at the hub.The characteristics of the damage could not be inspected from the video provided.Based on the information provided, possible contributing factors include damage during handling and over-tightening.Since a hub leak was observed, the complaint is confirmed but the exact cause remains unknown.H3 other text: evaluation findings are in section h11.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM PRE-CURVED 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: 17060557
• Report Number: 3006260740-2023-02262
• Device Sequence Number: 17434401
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K090102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 5594150
• Device Lot Number: REFV0737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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: Other
• Patient Sex: Unknown