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

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Minicap extended life pd (peritoneal dialysis) transfer set can be damaged if it comes into contact with cleaning products or solvents.Fda safety report id #(b)(4).

• Brand Name: PD TRANSFER SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 15708228
• Report Number: MW5113000
• Device Sequence Number: 14182961
• Product Code: KDJ
• UDI-Device Identifier: 00085412050867
• UDI-Public: 0085412050867
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/29/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2022
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American