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)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a connection issue between a titanium adapter and transfer set.The titanium adapter disconnected from the transfer set.This occurred during use of the devices for peritoneal dialysis therapy.The titanium adapter and transfer set were replace.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction made to b5: it was reported that there was a connection issue between a titanium adapter and transfer set.The titanium adapter disconnected from the transfer set.This occurred during use of the devices for peritoneal dialysis therapy.The titanium adapter was disinfected (previously reported as replaced) and re-installed and the transfer set was replaced.Three days later the titanium adapter disconnected from the transfer set again.The titanium adapter and transfer were both replaced.There was no report of patient injury or medical intervention associated with this event.No additional information is available.H11: should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h6 and h11.H11: the actual device and a photograph of the sample was received for evaluation.Visual inspection of the actual sample did not identify any abnormalities that could have contributed to the reported condition.The photograph was reviewed and showed a titanium sleeve wrapped in plastic.A functional or leak test could not be performed as the titanium adaptor was not returned with the titanium sleeve.The reported condition was not verified.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: 22883354
• Report Number: 9612168-2025-00022
• Device Sequence Number: 18358137
• 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,Followup
• Report Date (Section B): 09/18/2025

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: Other
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 09/12/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 08/27/2025; 09/22/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRANSFER SET.
• Patient Sex: Unknown