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 Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient line cap was missing on an unspecified quantity of extension sets (reported as "several").The issue was described as brand-new patient extension line in a sealed package ¿did not have a cap on the patient connection side¿.This was identified when patient was beginning set up of the machine 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: d9, h3, h6 and h11.H11: the device was received for evaluation.Visual inspection was performed and a missing large blue pull ring cap was observed.The reported condition was verified.The cause of the condition was determined to be a manufacturing related issue possibly caused by a slight misalignment.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 north highway 201; mountain home AR 72653
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24314059
• Report Number: 2314912-2026-00094
• Device Sequence Number: 4863284
• Product Code: KDJ
• UDI-Device Identifier: 00085412087382
• UDI-Public: 0085412087382
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K925403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 5C4480C
• Device Lot Number: H25J09077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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