MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. ONE-LINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7N8300

Device Problem Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/01/2017

Event Type  malfunction  

Event Description

The patient needed to be changed and turned.Three nurses were in the room to help, went into room with other nurses to find blood on bed; and when looked closely the t connector had separated toward the hub-end where the catheter is inside a hard plastic protector.The iv was saved with a lot of help.

• Brand Name: ONE-LINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 911 north davis; cleveland MS 38732
• MDR Report Key: 6621765
• MDR Text Key: 76981382
• Report Number: 6621765
• Device Sequence Number: 1
• Product Code: FPA
• 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: 05/09/2017

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: 7N8300
• Device Catalogue Number: 7N8300
• Device Lot Number: (10)UR16L08076
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR