MAUDE Adverse Event Report: BD / CAREFUSION 303, INC. BD IV TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 11522558

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

We routinely utilize these tubing sets for administration of medications: bd iv set 11522558.Starting about a year ago we started seeing an increase in pulling air into the line.This creates many risks: risk to patient should the air reach the patient; impact to patient if they are unable to receive all the medication; risk to patient for increase risk of clabsi when additional tubing may need to be utilized for patient to receive all the medication; risk to staff because many of these medications are hazardous medications and manipulating tubing increases risk of exposure.We met with bd who is investigating a change in the design of the ball chamber in this tubing.Staff have observed that this design changed around the time that these air in line issues began.Fda safety report id# (b)(4).

• Brand Name: BD IV TUBING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION 303, INC.
• MDR Report Key: 14117547
• MDR Text Key: 289443442
• Report Number: MW5109000
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other