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

Model Number	7N8310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Iv catheter and tubing came apart during iv contrast dye infiltration (smiths medical iv catheter and baxter one-link extension set).

• Brand Name: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 7361408
• Report Number: 7361408
• Device Sequence Number: 11066724
• Product Code: FPA
• UDI-Device Identifier: 00085412476728
• UDI-Public: (01)00085412476728
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2018
• Report Date (Section F): 03/15/2018

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?: Yes
• Operator of Device: No Information
• Device Model Number: 7N8310
• Device Catalogue Number: 7N8310
• Device Lot Number: (10)UR17K26020
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMITHS MEDICAL IV CATHETER
• Patient Age: 37 YR
• Date Report Sent to FDA: 03/15/2018