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

Catalog Number	5C4483
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was leak a leak in a minicap transfer set and ¿adaptor parts¿.This was further described as the leak occurred ¿between titanium adapter and beige catheter adapter connecter¿of the transfer set.This was observed during use of the device for peritoneal dialysis therapy.The titanium adapter was not exchanged.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B3: event date: the event occurred on an unknown date of (b)(6) 2026.D10: concomitant product: the event occurred on an unknown date of (b)(6) 2026.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction made to g4: pma/510k # or bla #: k192705 (previously submitted as na).Additional information was added to h6 & h11.H11: the actual device was not available; however, a companion sample was 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 were observed.Integrity of seal surface test was performed and no issues or leaks were observed.The reported condition was not verified.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: MINICAP
• 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: 24718886
• Report Number: 2314912-2026-00198
• Device Sequence Number: 6121888
• Product Code: KDJ
• UDI-Device Identifier: 00085412007748
• UDI-Public: (01)00085412007748(10)H24L06062(17)291206
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K192705
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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: Other
• Device Catalogue Number: 5C4483
• Device Lot Number: H24L06062
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/21/2026
• 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
• Patient Sex: Unknown