MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A

Model Number SL-2000M2095

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical 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 the user facility: event 3: detailed inquiry description: the arterial hub of the line that connects to the dialyzer is not glued or secured to the actual line.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Event 3: one (used) sample without packaging was submitted to the manufacturer for evaluation.Through visual examination, it was noted that the arterial connector on the blood set was missing from the end.The tubing was valued under magnification with little to no solvent observed on the end of the tubing.The reported defect is confirmed.A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.The defect is a result of a failure in the production process; a poor solvent application technique was presented in the line tube.An approved project is in place to further address issues with poor solvent application.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: SET, TUBING, BLOOD, WITH A
• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16713168
• MDR Text Key: 313140852
• Report Number: 2521402-2023-00078
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367762
• UDI-Public: (01)04046964367762
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2000M2095
• Device Catalogue Number: SL-2000M2095
• Device Lot Number: A2200732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2022
• 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