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 Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3/d10: the event occurred on an unspecified date in april 2025, reported as "last week." e1: initial reporter facility name: (b)(6).E1: initial reporter address: (b)(6).E1: initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was a connection issue between the titanium adapter and non-vantive catheter; further described as "the titanium connector detached from the catheter." this occurred during testing of the device in which light traction was applied between the titanium adapter and non-vantive catheter.A peri-patch repair was completed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Leak testing, functional testing, and assembly of the titanium adapter and sleeve was performed, and no issues were observed.The reported condition was not verified.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; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - SWINFORD; foxford road; swinford, county mayo ; EI
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 21995985
• Report Number: 9612168-2025-00010
• Device Sequence Number: 14531025
• Product Code: KDJ
• UDI-Device Identifier: 00085412007403
• UDI-Public: (01)00085412007403(10)24G08H93(17)290628
• 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,Followup
• Report Date (Section B): 11/06/2025

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: Health Professional
• Device Catalogue Number: 5C4129
• Device Lot Number: 24G08H93
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 10/29/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/10/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: NON-VANTIVE CATHETER.
• Patient Sex: Unknown