MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. STREAMLINE AIRLESS SYSTEM SET UP FOR B BRAUN DIALOG MACHINES; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Lot Number 00VL830884

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Dialysis lines came with kink in them.Discovered prior to reaching patient.Fda safety report id# (b)(4).

• Brand Name: STREAMLINE AIRLESS SYSTEM SET UP FOR B BRAUN DIALOG MACHINES
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 15893761
• MDR Text Key: 304696841
• Report Number: MW5113548
• Device Sequence Number: 1
• Product Code: KOC
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 00VL830884
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1