MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	L5C4366
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity (at least a few) of ultra set capd disposable disconnect y-sets leaked.This occurred during setup/preparation of the devices for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h6 and h11.H11: the device was received for evaluation.Functional testing including leak, clear passage, and clamp function testing were performed.The visual inspection, by the naked eye, along with the functional testing observed a leak from a cut/hole/slice on the front and back side of the bag.The reported condition was verified.The cause was undetermined, however, it is possible a sharp object caused the damage.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 22337643
• Report Number: 2314912-2025-00672
• Device Sequence Number: 18409480
• Product Code: KDJ
• UDI-Device Identifier: 00085412090085
• UDI-Public: (01)00085412090085(10)H25C09030(17)270309
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K961825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: Lay User/Patient
• Device Catalogue Number: L5C4366
• Device Lot Number: H25C09030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2025
• 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