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	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
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 a locking titanium adapter had a damaged pouch.This was observed before use of the device for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h6 and h11.H11: the actual device and a photograph were received for evaluation.A visual inspection of the actual sample was performed and a slit was observed on the back of the pouch.The photograph was reviewed and showed the front of a pouch over labelled with a chinese text label indicating that the product was repacked and relabelled in china.The reported condition was verified.The cause of the damage was due to a shipping distribution issue.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: 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: 23452165
• Report Number: 9612168-2025-00031
• Device Sequence Number: 8073767
• Product Code: KDJ
• UDI-Device Identifier: 00085412007403
• UDI-Public: (01)00085412007403(10)24I09H93(17)290828
• 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): 11/25/2025

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: 24I09H93
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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
• Patient Sex: Unknown