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

Catalog Number	5C4482
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 minicap transfer set leaked with the twist clamp closed.This occurred during use of the device for peritoneal dialysis therapy.The transfer set was replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information d9, h3, h6, and h11.H11: the device was received for evaluation.A visual inspection with the naked eye was performed which observed a broken occluder leg which caused a leak through the set.Functional tests were performed which included leak, clear passage, and clamp function tests and a leak through the closed clamp was observed.The reported condition was verified.The cause of the leak was due to the broken occluder leg.The cause of the broken occluder leg could not be determined, however, if the set was exposed to chemical agents such as hydrogen peroxide, alcohol or bleach, as listed on product packaging, this could damage the transfer set materials.A batch review was conducted and there were no deviations found related to this reported 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: 24314501
• Report Number: 2314912-2026-00096
• Device Sequence Number: 4942317
• Product Code: KDJ
• UDI-Device Identifier: 00085412007731
• UDI-Public: (01)00085412007731(10)H25F13035(17)300613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152675
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 5C4482
• Device Lot Number: H25F13035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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: NI.
• Patient Sex: Unknown