MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4129
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the titanium adapter disconnected from an unspecified tube which resulted in a leak.This occurred during use of the device for peritoneal dialysis therapy.The titanium adapter was replaced.There was no report of patient injury or medical intervention associated with this event; however, the patient was treated with ancef 1.5g.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
D4: the lot number is unknown, therefore, only a primary di number could be provided.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
B5: during follow up, it was clarified that there was a disconnection between the minicap transfer set and titanium adapter which resulted in a leak.Both the transfer set and titanium adapter were replaced.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - SWINFORD; foxford rd.; swinford, county mayo ; EI
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24471573
• Report Number: 9612168-2026-00017
• Device Sequence Number: 21409575
• Product Code: KDJ
• UDI-Device Identifier: 07332414207946
• UDI-Public: 7332414207946
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/05/2026

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: 5C4129
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MINICAP TRANFER SET.; NI.
• Patient Sex: Unknown