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

Model Number SL-2010M2096

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

As reported by user facility: foreign matter was found inside the bloodline.There was no patient involvement.

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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).A tubing set and a photograph were provided for evaluation.All information associated with this event was submitted to the bloodline manufacturer.According to the investigation, the tubing set and photo were both visually inspected with a black mark being observed on the tubing near the venous chamber, confirming the reported issue.Photographs were provided to manufacturing for review.Manufacturing was unable to determine the root cause of this issue based on the available information.All products are released meeting quality criteria and manufacturing specifications.A search of the complaint database for the blood tubing set lot numbers 10554024 and 10554025 showed no additional complaints of a similar nature as of complaint closure, indicating this is an isolated occurrence.10554025 showed no additional complaints of a similar nature as of complaint closure, indicating this is an isolated occurrence.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: BLOOD TUBING SETS
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 824 12th avenue; bethlehem PA 18018 0027
• Manufacturer (Section G): B. BRAUN MEDICAL INC; 824 12th avenue; bethlehem PA 18018 0027
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12954233
• MDR Text Key: 281868995
• Report Number: 2521402-2021-00088
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367786
• UDI-Public: (01)04046964367786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2010M2096
• Device Catalogue Number: SL-2010M2096
• Device Lot Number: 10554025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1