MAUDE Adverse Event Report: Vantive US Healthcare LLC MINICAP WITH POVIDONE-IODINE SOLUTION; Set, Administration, For Peritoneal Dialysis, Disposable

Catalog Number	5C4466P
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: MINICAP WITH POVIDONE-IODINE SOLUTION
• Common Device Name: Set, Administration, For Peritoneal Dialysis, Disposable
• Manufacturer (Section D): Vantive US Healthcare LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - CUERNAVACA; calle 50 metros; civac, jiutepec morelos NA 62578 ; MX 62578
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; +1(815)307-2966
• MDR Report Key: 50224309
• Report Number: 8030639-2026-00017
• Device Sequence Number: 18750933
• Product Code: KDJ
• UDI-Device Identifier: 00085412007694
• UDI-Public: (01)00085412007694(10)M25F30B(17)270630
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 5C4466P
• Device Lot Number: M25F30B
• 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: 07/30/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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
• Patient Sex: Unknown