MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CAPD DISCONNECT Y SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4366P
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a capd disconnect y set leaked; further described as ¿the floor was wet due to leakage¿.This occurred during use of the device for continuous ambulatory peritoneal dialysis (capd) therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The actual sample was returned for evaluation.Visual inspection was performed and a cut in the bag was observed.Functional testing was performed and a leak from a cut in the bag located at the top corner of the bag was identified.Clear passage and clamp function testing were performed and no issues were observed.The reported condition was verified.The direct cause was determined to be manufacturing related issue caused by the stripper plate being out of alignment during the removal of the excess material.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: CAPD DISCONNECT Y SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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: 19234397
• Report Number: 1416980-2024-02054
• Device Sequence Number: 17622316
• Product Code: KDJ
• UDI-Device Identifier: 00085412030579
• UDI-Public: (01)00085412030579
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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 Catalogue Number: 5C4366P
• Device Lot Number: H23F19125
• 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: 04/09/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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