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

Catalog Number	5C4482A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the lot number is unknown, therefore, only a primary di number could be provided.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the twist clamp of the minicap transfer set broke.This occurred during use of the device for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event, however the patient was treated with intraperitoneal (ip) 2gm ceftazidime and 1gm vancomycin.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 & h11: h11: the device was received for evaluation with the twist clamp in open position and a mini cap attached.Visual inspection was performed and broken occluder legs were observed.Leak, clear passage, and clamp function testing were performed and a leak through the set due to broken occlude legs was observed.The reported condition was verified.The cause of the broken occluder legs could not be determined, however; exposure to chemical agents such as hydrogen peroxide, alcohol or bleach as listed on the product packaging can damage the transfer set materials.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP EXTENDED LIFE PD TRNS
• 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: 24578486
• Report Number: 2314912-2026-00166
• Device Sequence Number: 13343674
• Product Code: KDJ
• UDI-Device Identifier: 00085412841625
• UDI-Public: 0085412841625
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: Other
• Device Catalogue Number: 5C4482A
• Device Lot Number: ASKU
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female
• Patient Weight: 85 KG