MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. EXTENSION SET WITH EASY-LOCK CONNECTOR; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4480C
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient line extension set had a hole.This was noticed during set up of the device for peritoneal dialysis therapy.The patient started over with new supplies.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the device was received for evaluation.A visual inspection with the naked eye noted a cut in the tubing.A functional clear passage test was performed with no issues noted.Leak testing failed due to the leak from the cut in the tubing.The reported condition was verified.The cause of the condition could not be determined.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 WITH EASY-LOCK CONNECTOR
• 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: 20408756
• Report Number: 1416980-2024-05580
• Device Sequence Number: 3378946
• Product Code: KDJ
• UDI-Device Identifier: 00085412087382
• UDI-Public: (01)00085412087382(10)H24D19061(17)260419
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/11/2024

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: 04/19/2026
• Device Catalogue Number: 5C4480C
• Device Lot Number: H24D19061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• 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: HOMECHOICE CLARIA
• Patient Sex: Unknown