MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER STANDARD BORE CATHETER EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2N1333

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2022

Event Type  malfunction  

Event Description

Baxter standard bore catheter extension set does not have hub to thread.It is defective.Ref# 2n1333, lot (10)ur22d19017.

• Brand Name: BAXTER STANDARD BORE CATHETER EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 15931695
• MDR Text Key: 304969307
• Report Number: 15931695
• 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: 11/28/2022

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 Model Number: 2N1333
• Device Catalogue Number: 2N1333
• Device Lot Number: UR22D19017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2022
• Event Location: Other
• Date Report to Manufacturer: 12/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1