MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. FILTERED EXTENSION SET 1.2; SET, ADMINISTRATION, INTRAVASCULAR

Model Number FE1212F

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2019

Event Type  malfunction  

Event Description

Rn hanging sterile fluids for fluid line change discovered filter set would fill with air during line change set up contributing to air in primed line.

• Brand Name: FILTERED EXTENSION SET 1.2
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 8826550
• MDR Text Key: 152465366
• Report Number: MW5088369
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FE1212F
• Device Lot Number: 0061673125
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 DA