MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. B. BRAUN IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Protective Measures Problem (3015)

Patient Problem Insufficient Information (4580)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

Multiple alarms while using the b.Braun pumps and disposable tubing."air in line" alarms repeatable alarming due to tubing malfunction.Resulting in significant delay in care up to 45 minutes in duration.Staff are unable to clear "air in line" alarms resulting in ergonomic related injuries.Fda safety report id# (b)(4).

• Brand Name: B. BRAUN IV TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 15753893
• MDR Text Key: 303326531
• Report Number: MW5113114
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/03/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other