MAUDE Adverse Event Report: BAXTER INTERNATIONAL, INC. BAXTER NON-DEHP STANDARD BORE CATHETER EXTENSION SET-POWER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2N1333

Device Problems Fluid/Blood Leak (1250); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/24/2019

Event Type  malfunction  

Event Description

Noticed iv was leaking during free maintenance drip after iv start in pre-post.Extension set failure: male luer lock adapter was loose at the point of where it is normally bonded to the rest of the extension piece.Extension was changed and upon inspection the male luer lock was easily displaced from the rest of the extension set.

• Brand Name: BAXTER NON-DEHP STANDARD BORE CATHETER EXTENSION SET-POWER
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL, INC.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 8669723
• MDR Text Key: 147031704
• Report Number: 8669723
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2019

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: Other
• Device Model Number: 2N1333
• Device Catalogue Number: 2N1333
• Device Lot Number: 10 UR 19A26010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1