MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER Y TYPE BLOOD SOLUTION SET WITH STANDARD BLOOD FILTER; SET, BLOOD TRANSFUSION

Lot Number DR20 J20020

Device Problem Break (1069)

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

Event Date 12/21/2020

Event Type  malfunction  

Event Description

When spiking the unit of blood the spike part of tubing broke off.

• Brand Name: BAXTER Y TYPE BLOOD SOLUTION SET WITH STANDARD BLOOD FILTER
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 11064968
• MDR Text Key: 223614112
• Report Number: MW5098505
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: DR20 J20020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1