MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. STREAMLINE AIRLESS SYSTEM SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Lot Number 00VL916625

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

Approximately 200 cc blood loss during hemodialysis treatment from b.Braun streamline bloodline.Small hole in line.

• Brand Name: STREAMLINE AIRLESS SYSTEM SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 18960124
• MDR Text Key: 338492187
• Report Number: MW5153054
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 00VL916625
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1