MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC HOMECHOICE APD SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C4469C
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were scratches on the pipe (tubing) wall of fifteen (15) homechoice cassettes.This was identified before use of the devices for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information added to h11: during evaluation of the returned samples, deep scratches were present that caused material slivering on the tubing and were detectable by touch with a fingernail.The slivering on the tubing indicated penetration to the tubing wall and is not considered as surface marks but characterized as cuts.A leak test was performed on one patient line tubing sample, and no leaks were observed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE APD SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• 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: 24925490
• Report Number: 2314912-2026-00241
• Device Sequence Number: 16115316
• Product Code: FKX
• UDI-Device Identifier: 07332414208479
• UDI-Public: 7332414208479
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K923065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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: 5C4469C
• Device Lot Number: H25H17016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 05/26/2026; 06/19/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/29/2026; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2025
• 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