MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NON-DEHP EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Defective Component (2292); Priming Problem (4040)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2022

Event Type  malfunction  

Event Description

Non-dehp extension set filter looks like the filter is defective.While nurse was priming the line she noticed the filter was abnormal.Fda safety report id #(b)(4).

• Brand Name: NON-DEHP EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 15322331
• MDR Text Key: 299012677
• Report Number: MW5111804
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1