MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC EXTENSION SET WITH EASY-LOCK CONNECTOR; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4480C
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
A peritoneal dialysis (pd) patient experienced a leak from a patient extension line.It was reported that there was "holes/slits in patient extension line" and noticed a "pool of fluid on the floor".It was further reported that the patient extension line had a defect described as a pinhole.It was reported the patient was diagnosed with peritonitis 3 days after the reported leak.The cause of the peritonitis was reported as unknown.On the same date as the diagnosis, it was reported that the patient was hospitalized for four days.The patient was treated with unspecified medication.The patient was reported to have recovered from the event.Action taken with pd therapy was not reported.No additional information is available.
Additional Manufacturer Narrative
Additional information: h6.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SET WITH EASY-LOCK CONNECTOR
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; roundlake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 north highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 22722520
• Report Number: 2314912-2025-00814
• Device Sequence Number: 21228247
• Product Code: KDJ
• UDI-Device Identifier: 00085412087382
• UDI-Public: (01)00085412087382(10)H24L12037(17)261212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K925403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: Lay User/Patient
• Device Catalogue Number: 5C4480C
• Device Lot Number: H24L12037
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CYCLER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male