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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

Blood loss due to hole in medisystems streamline bloodline.

• Brand Name: STREAMLINE BLOODLINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): MEDISYSTEMS / B. BRAUN MEDICAL INC.
• MDR Report Key: 18885117
• MDR Text Key: 337536284
• Report Number: MW5152608
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other