MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK Y-TYPE BLOOD/SOLUTION SET W/ STANDARD BLOOD FILTER; SET, BLOOD TRANSFUSION

Catalog Number 2C8750S

Device Problems Leak/Splash (1354); Component Missing (2306); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

A tubing set we use for transfusions had a gaping tear.The nurse was preparing the infusion set, had it hanging from a iv holder and when she spiked the blood filled bag with the iv set, the blood ran into the tube and out of the gaping tear.A one inch section was missing about half of its material to make a complete circle.Imagine a canoe; it looks like a bite was taken out of a section of tubing.No patient harm.

• Brand Name: CLEARLINK Y-TYPE BLOOD/SOLUTION SET W/ STANDARD BLOOD FILTER
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois 120; rlt-10; round lake IL 60073
• MDR Report Key: 4593499
• MDR Text Key: 19720444
• Report Number: 4593499
• Device Sequence Number: 1
• Product Code: BRZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/27/2015

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: Nurse
• Device Catalogue Number: 2C8750S
• Device Lot Number: 07-36-69-408
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.