MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT CATHETER; DIALYSIS CATHETER

Catalog Number	5733730
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
A patient underwent a dialysis catheter placement procedure using the hemosplit hemodialysis catheter.Post the procedure, it was reported that the tip lumens of the catheter were allegedly separated.It was also reported that the catheter lumen broke during withdrawal from the skin, leading to post-procedural catheter dysfunction.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one sealed hemo split hemodialysis catheter was returned for sample evaluation.Gross, visual evaluations were performed.The complaint sample was noted to be clean.Components within kit did not appear affected.Kit was unsealed for evaluation purpose.The catheter was returned with both clamps disengaged.The tissue cuff was intact and was clean.Distinct curvature was noted on the center portion of the catheter.Tactile evaluation was performed catheter was gently stretched, and normal elasticity was noted.The tissue cuff did not move freely throughout the catheter.No kinks were noted.Both the red and blue luer and were patent to infusion and aspiration.No leaks were noted.Hydrostatic pressure was applied by clamping the distal end of the catheter while infusing to observe for leaks.No leak was noted on both the red and blue luers.Therefore, the investigation is inconclusive for the reported catheter fracture and material separation issues as reported sample was not return, and no anomalies were noted in returned lot sample.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.E1, g3, h6 (method, result, conclusion).Section a through f: the information provided 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.
Event or Problem Description
A patient underwent a dialysis catheter placement procedure using the hemosplit hemodialysis catheter.Post the procedure, it was reported that the tip lumens of the catheter were allegedly separated.It was also reported that the catheter lumen broke during withdrawal from the skin, leading to post-procedural catheter dysfunction.There was no reported patient injury.

• Brand Name: HEMOSPLIT CATHETER
• 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: 23152473
• Report Number: 3006260740-2025-07244
• Device Sequence Number: 15988835
• Product Code: MSD
• UDI-Device Identifier: 00801741000454
• UDI-Public: (01)00801741000454(11)250307(17)261130(10)REKN3482
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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 Catalogue Number: 5733730
• Device Lot Number: REKN3482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• 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