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

Model Number 2N1333

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

Inserted bd insyte autoguard 20g 1.88 under ultrasound guidance - utilized a standard extension set - after connecting the baxter extension set, i noticed the line did not have a retractable collar.Had to obtain another extension set to secure to line.

• Brand Name: NA
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 15931584
• MDR Text Key: 304969711
• Report Number: 15931584
• 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

• Date FDA Received: 12/07/2022
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Sex: Female
• Patient Race: Black Or African American