MAUDE Adverse Event Report: BAXTER BAXTER EXTENSION SET; ADMINISTRATION SET INTRAVASCULAR

Model Number	1C8363
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient receiving etoposide with baxter filter attached.Patient had chemo spilled upon them as it was noted that the filter was leaking.

• Brand Name: BAXTER EXTENSION SET
• Common Device Name: ADMINISTRATION SET INTRAVASCULAR
• Manufacturer (Section D): BAXTER
• MDR Report Key: 6885892
• Report Number: MW5072294
• Device Sequence Number: 13628053
• Product Code: FPA
• UDI-Device Identifier: 00085412013718
• UDI-Public: 085412013718
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1C8363
• Device Lot Number: GR332254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Weight: 42