MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EMPTY STERILE CONTAINER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C4462
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
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 an empty sterile container had a cracked in the connection port.This was observed before use of the device.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction made to a1: patient identifier: none (previously submitted as unknown).Correction made to a2-a6: na (previously submitted as ni).Correction made to b6: na (previously submitted as ni).Correction made to b7: na (previously submitted as ni).Correction made to d10: na (previously submitted as ni).Correction made to d2a: common device name: system, peritoneal, automatic delivery (previously submitted as set, administration, for peritoneal dialysis, disposable).Correction made to d2b: classification code: fkx (previously submitted as kdj).Correction made to f10/h6: health effect - impact codes: replace f26 with f27.H10: the device was received for evaluation with a white spike or patient connector connected to the molded port.A visual inspection with the naked eye noted a split/cut down the port of the drain bag.Functional testing including clear passage testing was performed with no issues noted.Leak testing failed due to the leak from the split in the bag port.The reported condition was verified.The direct cause was manufacturing related issue during the port tube process.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: EMPTY STERILE CONTAINER
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• 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: 17335688
• Report Number: 1416980-2023-03613
• Device Sequence Number: 11981917
• Product Code: FKX
• UDI-Device Identifier: 00085412007670
• UDI-Public: (01)00085412007670
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K833065
• 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): 08/16/2023
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 5C4462
• Device Lot Number: H23B27044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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: NI.
• Patient Sex: Unknown