MAUDE Adverse Event Report: CAREFUSION 303, INC.; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Break (1069); Material Rupture (1546)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

Fluid bolus being pushed manually through alaris pump tubing through draw port on picc line.During fluid bolus, alaris tubing burst distally site of manual push and tubing broke.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 10689398
• MDR Text Key: 211691307
• Report Number: 10689398
• 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: 10/02/2020

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1