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	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: d3: device manufacturer name: replace baxter healthcare corporation with baxter international inc.H11: fourteen samples were received for evaluation; the other nine samples were not received and therefore, could not be evaluated.A visual inspection, with the naked eye, was performed on the samples which observed cuts in the drain bags of four (4) samples.Functional testing was performed on the other ten (10) samples with no issues noted.The reported condition was not verified on ten (10) of the samples and was verified on four (4) of the samples only.The cause of the condition could not be determined; however, due to the position of the cuts in the bags, it appeared the sets were cut horizontally with a sharp object.No other issues were identified during the evaluation.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.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a peritoneal dialysis patient observed holes in 23 ultraset capd disposable disconnect y-sets priori to use.The cause of the holes was unknown.The caregiver reported they did not notice any damage with the overpouch prior to use.There was no patient involvement.No additional information is available.

• 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: 19629338
• Report Number: 1416980-2024-03265
• Device Sequence Number: 20682639
• Product Code: KDJ
• UDI-Device Identifier: 00085412090085
• UDI-Public: (01)00085412090085(10)H24B15014(17)260215
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 07/30/2024

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: 02/15/2026
• Device Catalogue Number: L5C4366
• Device Lot Number: H24B15014
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female