MAUDE Adverse Event Report: Vantive US Healthcare LLC MiniCap Transfer Set; Set, Administration, For Peritoneal Dialysis, Disposable

Catalog Number	5C4482A
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Peritonitis (2252)
Type of Reportable Event	Serious Injury

• Brand Name: MiniCap Transfer Set
• 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 ; +1(815)307-2966
• MDR Report Key: 50847663
• Report Number: 2314912-2026-00617
• Device Sequence Number: 9497638
• Product Code: KDJ
• UDI-Device Identifier: 00085412841625
• UDI-Public: (01)00085412841625(10)H24K22046(17)291122
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: Health Professional
• Device Catalogue Number: 5C4482A
• Device Lot Number: H24K22046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/21/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female