MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK Y-TYPE; SET, BLOOD TRANSFUSION

Model Number 2C8750S

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2016

Event Type  malfunction  

Event Description

When the nurse was setting up the blood infusion set and was priming the normal saline through the tubing prior to administering blood products, it was noted that the tubing had a leak/hole in the tubing.

• Brand Name: CLEARLINK Y-TYPE
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 911 north davis; cleveland MS 38732
• MDR Report Key: 6154377
• MDR Text Key: 61773178
• Report Number: 6154377
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2016

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: No Information
• Device Model Number: 2C8750S
• Device Catalogue Number: 2C8750S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2016
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1