MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Contamination (1120)

Patient Problem Test Result (2695)

Event Date 09/05/2018

Event Type  No Answer Provided  

Event Description

Labs drawn from clear pressure caps.Labs hemolyzed.Staff reported increased incident of hemolyzed labs during use of one-link pressure caps.

• Brand Name: ONE-LINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 9353501
• MDR Text Key: 167342711
• Report Number: 9353501
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2019,10/04/2018

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2019
• Date Report to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA