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

Catalog Number	5C4483
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
A peritoneal dialysis (pd) patient experienced leaking from a transfer set.It was further reported the transfer set disconnected from the non-vantive plastic adapter.The patient went into the clinic after the disconnection and the transfer set was replaced.Subsequently, the patient experienced peritonitis and was prescribed unspecified intraperitoneal antibiotics for three weeks.The patient was not hospitalized.On an unspecified date, the patient recovered from the event.Action taken with pd therapy was not reported.No additional information is available.

• 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: 24730475
• Report Number: 2314912-2026-00202
• Device Sequence Number: 15770570
• Product Code: KDJ
• UDI-Device Identifier: 00085412007748
• UDI-Public: 00085412007748
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K192705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 5C4483
• 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
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PLASTIC ADAPTER - MANUFACTURER UNSPECIFIED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male