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

Model Number	7N8310
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
16 cases of the baxter one-link and smiths medical jelco iv catheter separating during power injection required for ct scan.This has lead to the patients being required to receive reinjection and reimaging.Appears to be secondary to the two devices not being compatible with one another.Manufacturer response for catheter,intravascular,therapeutic,short-term less than 30 days, jelco (per site reporter).Inservices have been provided to staff by baxter and smith's medical regarding the use of these two devices together with less than optimal results.Manufacturer response for set, administration, intravascular, one-link (per site reporter).Both baxter and smith's medical have provided several inservices in an attempt to address any education issues which might be at hand.Inservices have not been as effective as planned and these two devices have continued to produce issues during power injections.

• Brand Name: ONE-LINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 9202758
• Report Number: 9202758
• Device Sequence Number: 18944722
• Product Code: FPA
• UDI-Device Identifier: 00085412476728
• UDI-Public: (01)00085412476728
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/27/2019
• Report Date (Section F): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7N8310
• Device Catalogue Number: 7N8310
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/27/2019