MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 RELIANCE XK LONG-TERM HEMODIALYSIS CATHTER, PLOYURETHANE, KIT, 16F; DIALYSIS CATHETER

Catalog Number	5323190
Medical Device Problem Codes	Difficult to Flush (1251); Suction Problem (2170); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a dialysis catheter placement procedure, the wire was difficult to thread through the arterial port of the catheter.It was further reported that tried to aspirate through the port, there was resistance felt.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.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.
Event or Problem Description
On (b)(6) 2025, a patient underwent for a dialysis catheter placement procedure was reported that during a dialysis catheter placement procedure in the right subclavian vein using reliance xk long-term hemodialysis catheter, ployurethane, kit, 16f.During the procedure, the wire was difficult to thread through the "arterial" port of the catheter.It was further reported that tried to aspirate through the port, there was resistance felt.Reportedly it was noted that the end piece of the catheter was slightly bent or tight.The procedure was completed using another device.Catheter was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as this is the only complaint reported for this lot number.Investigation summary: one 19cm reliance xk d/l catheter was returned for evaluation.Along with returned sample, one photo was provided for review.Visual, microscopic, tactile, functional and borescope evaluations were performed.The complaint sample appeared to have residue throughout.The blue luer was patent to infusion and aspiration.The red luer was patent to infusion and aspiration.No leaks were observed throughout the catheter.The fiber tip of the borescope was inserted into both the blue and red luers and no anomalies were noted.Therefore, the investigation is unconfirmed for the reported deformation and suction problem as no issues were identified during sample evaluation.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, g2, g3, h6 (device, component, method, result, conclusion).Section a through f: the information provide by bd represents all 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: RELIANCE XK LONG-TERM HEMODIALYSIS CATHTER, PLOYURETHANE, KIT, 16F
• Common Device Name: DIALYSIS CATHETER
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21408563
• Report Number: 3006260740-2025-00783
• Device Sequence Number: 9345053
• Product Code: MSD
• UDI-Device Identifier: 00801741011986
• UDI-Public: (01)00801741011986(17)251130(10)REJN0935
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 11/30/2025
• Device Catalogue Number: 5323190
• Device Lot Number: REJN0935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown