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

Model Number 2N3348

Device Problem Flushing Problem (1252)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2019

Event Type  malfunction  

Event Description

Microbore medfusion tubing ( 0.44 ml) would not flush anything through as though there was an occlusion in the tubing.Two episodes within the same lot # had the same problem.No harm to the patient; attempting to set up infusion.Manufacturer response for microbore tubing, (brand not provided) (per site reporter) manufacturer will be contacted via our materials management department.

• Brand Name: MICRO-VOLUME
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 32650 n. willson blvd wgl-3n; round lake IL 60073
• MDR Report Key: 9530070
• MDR Text Key: 173021905
• Report Number: 9530070
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/26/2019

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: Health Professional
• Device Model Number: 2N3348
• Device Catalogue Number: 2N3348
• Device Lot Number: UR19107013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1