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

Catalog Number	5C4483
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the twist clamp separated from the main body of the minicap transfer set.This occurred when the patient attempted to twist the clamp.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 h6 and h11: h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was reviewed and showed a separation between the main body and twist clamp caused by broken occluder legs.The reported condition was verified.The cause of the condition could not be determined, however; exposure to chemical agents such as hydrogen peroxide, alcohol or bleach as listed on product packaging can damage the transfer set materials.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information added to d1: brand name, d4: catalogue #, d4: unique identifier (udi) #, and g4: pma/510k # or bla #.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: 24247488
• Report Number: 2314912-2026-00065
• Device Sequence Number: 15945073
• Product Code: KDJ
• UDI-Device Identifier: 00085412007748
• UDI-Public: 0085412007748
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 03/09/2026

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: 5C4483
• Device Lot Number: ASKU
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/13/2026; 02/26/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 02/26/2026; 03/09/2026
• 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