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

Catalog Number	5C4480C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
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 12 foot extension set leaked where the tubing meets the white connector.The tubing was not placed onto the patient extension connector piece correctly and the end of the tubing was exposed allowing the fluid to leak between the tubing and white connector components.This was observed during use of the device for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.A visual inspection with the naked eye noted an incomplete heat seal bead on the tubing to the patient connector.The reported condition was verified.The cause of the condition was determined to be a manufacturing related issue occurred during the rf (radio frequency) welding process between the patient line and the patient connector.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION 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: 18291280
• Report Number: 1416980-2023-06402
• Device Sequence Number: 6206823
• Product Code: KDJ
• UDI-Device Identifier: 00085412087382
• UDI-Public: (01)00085412087382
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K925403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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: Lay User/Patient
• Device Expiration Date: 08/15/2025
• Device Catalogue Number: 5C4480C
• Device Lot Number: H23H15079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRANSFER SET
• Patient Sex: Unknown