MAUDE Adverse Event Report: B. BRAUN MEDICAL INC HEMODIALYSIS BLOODLINES; BLOOD TUBING SETS

Model Number SL-2010M2096

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by user facility: staff noticed blood dripping from the arterial connection upon hd tx start.It was noted that the male end of the arterial line broke off inside the female end of the fistula needle tubing.This caused the patient to have a new setup.No injuries reported.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).All information associated with this event was submitted to the bloodline manufacturer.According to the manufacturer's investigation, the blood tubing set was returned for evaluation.The complaint was confirmed as the arterial luer was broken.Pictures of the returned set were provided to their manufacturing team for review, however they were unable to determine the root cause of the issue based on the available information.A review of the device history records for 2000m2095d from lot 10154043 was performed and indicated that there were no quality issues during the manufacturing process of this lot related to the reported issue.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: BLOOD TUBING SETS
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 824 12th avenue; bethlehem PA 18018 0027
• MDR Report Key: 11913245
• MDR Text Key: 253515030
• Report Number: 2521402-2021-00023
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367786
• UDI-Public: (01)04046964367786
• Combination Product (y/n): N
• PMA/PMN Number: K080807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: SL-2010M2096
• Device Catalogue Number: SL-2010M2096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1