MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK EXTENSION SET WITH CONTROL-A-FLO REGULATOR; STOPCOCK I.V. SET

Catalog Number 2C8891

Device Problem Break (1069)

Patient Problems Missed Dose (2561); Blood Loss (2597)

Event Date 10/08/2019

Event Type  Injury  

Event Description

During cardiac catheterization procedure, control-a-flo regulator on iv extension tubing broke preventing pt from receiving sedative medications, heparin, and iv fluids.Pt had some small volume blood loss.Device was removed, iv tubing replaced, and procedure continued with no further issues.

• Brand Name: CLEARLINK EXTENSION SET WITH CONTROL-A-FLO REGULATOR
• Type of Device: STOPCOCK I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION ; deerfield IL
• MDR Report Key: 9328941
• MDR Text Key: 166928880
• Report Number: MW5091123
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8891
• Device Lot Number: (10) DR19F13066
• Was Device Available for Evaluation?: Yes
• 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: 67 YR
• Patient Weight: 83