MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	L5C4366
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a capd disconnect y set leaked; further described as "leaking upon initial drain at the top of the drain bag where the tubing connects to the bag" and "fluid on the floor".This was observed during the initial drain step of continuous ambulatory peritoneal dialysis (capd) therapy; the device was clamped and disconnected.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H11: the device was received for evaluation.A visual inspection with the naked eye noted an insufficient port seal and black particulate matter (pm) was observed.Functional testing including clear passage and clamp function tests were performed with no issues noted.Leak testing identified a leak at the port seal were the pm was located.The reported condition was verified.The cause of the leak was due to an insufficient port seal and the black pm which was residual from an arc during the radio frequency welding process, which occurred during the manufacturing process.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: ULTRASET CAPD DISPOSABLE DISCONNECT Y-SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20076916
• Report Number: 1416980-2024-04530
• Device Sequence Number: 20434332
• Product Code: KDJ
• UDI-Device Identifier: 00085412090085
• UDI-Public: (01)00085412090085(10)H23H10088(17)250810
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K961825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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 Expiration Date: 08/10/2025
• Device Catalogue Number: L5C4366
• Device Lot Number: H23H10088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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