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

Model Number 1C8363

Device Problem Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 09/20/2017

Event Type  Injury  

Event 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
• Type of Device: ADMINISTRATION SET INTRAVASCULAR
• Manufacturer (Section D): BAXTER
• MDR Report Key: 6885892
• MDR Text Key: 87202089
• Report Number: MW5072294
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412013718
• UDI-Public: 085412013718
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1C8363
• Device Lot Number: GR332254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 42