MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. FILTERED EXTENSION SET 16IN; FILTER, INFUSION LINE

Model Number FE2012F

Device Problem Leak/Splash (1354)

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

Event Type  No Answer Provided  

Event Description

After ocrevus finished infusing, and staff was taking it down, staff noted there was a puddle on the floor.On investigation, staff noted there was a leak from the iv tubing.Approximately 75- 100ml (about 120 mg) of medication had leaked onto the floor.Did receive remainder of infusion, approximately 150-170 ml or 180 mg.Provider aware, a leak in the filter extension set was noticed near the yellow port.

• Brand Name: FILTERED EXTENSION SET 16IN
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 7938716
• MDR Text Key: 123489441
• Report Number: MW5080386
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: FE2012F
• Device Catalogue Number: 473989
• Device Lot Number: 0061618776
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR