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 Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 three (3) minicaps transfer sets disconnected at an unspecified location which resulted in a leak.The patients had huge leaks on their pants and clothing.For two patients the event occurred while cutting their front yard grass.For one patient the event occurred while preparing their meal.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 d1: brand name, d4: catalogue #, d4: lot #, d4: expiration date, d4: unique identifier (udi) #, d9, g4: pma/510k # or bla #, h3, h4: device manufacture date, h6, and h11: h11: two (2) actual devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Leak, clear passage, and clamp function testing were performed, and no issues or leaks were observed.Integrity testing was performed; the patient adapter was tightened to an in-lab titanium adapter and leak tested and no issues or leaks were observed.Torque engagement testing was performed and the engage and disengage force was within specification.The reported condition was not verified.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: 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: 24365801
• Report Number: 2314912-2026-00117
• Device Sequence Number: 5315443
• Product Code: KDJ
• UDI-Device Identifier: 00085412841625
• UDI-Public: (01)00085412841625(10)H25I23061(17)300923
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: H25I23061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown