MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC MINICAP EXTENDED LIFE PD TRNS; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4482A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot #: the reported lot # h25c25415 is not recognized by the system.E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the female connector of the minicap transfer set was broken.There was a separation issue with the female connector when disconnecting from the cycler patient line after peritoneal dialysis therapy.The patient was able to disconnect safely.The transfer set was replaced.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 d9, h3, h6 and h11.H11: one (1) actual sample was returned for evaluation.A visual inspection by the naked eye was performed with no issues observed.Functional tests which included leak, clear passage, and clamp function tests were performed with no issues and no leaks observed.Solvent bond check/twist test was performed; the female connector and the main body were twisted by hand with no issues and no separation of components noted.The reported condition was not verified.The sample met specifications.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP EXTENDED LIFE PD TRNS
• 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: 24334825
• Report Number: 2314912-2026-00107
• Device Sequence Number: 18587252
• Product Code: KDJ
• UDI-Device Identifier: 00085412841625
• UDI-Public: 0085412841625
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K152675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: 5C4482A
• Device Lot Number: H25C25415
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CASSETTE; CYCLER
• Patient Sex: Unknown