MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CONTINU-FLO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2C8541, 2R8480

Device Problems Fluid/Blood Leak (1250); Difficult to Flush (1251)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Event Description

Patient was receiving two chemo drugs.One had finished and there was a brief delay starting the next infusion.Port was accessed with safestep 20g 3/4" huber needle.Rn was unable to flush or obtain blood return from patient¿s port when it had previously been working, and clave at y site of port tubing noted to be leaking.Port was re-accessed and worked well without issue.

• Brand Name: CONTINU-FLO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15742992
• MDR Text Key: 303149380
• Report Number: 15742992
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2C8541, 2R8480
• Device Lot Number: UNKNOWN FOR BOTH
• 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: 10/24/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1