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

Catalog Number SL-2000M2095

Device Problem Leak/Splash (1354)

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

Event Date 09/25/2023

Event Type  malfunction  

Event Description

As reported by the user facility: detailed inquiry description: it was discovered that there was a blood leak at the junction between the blood pump and the dialyzer at the point where the "pink" capped connecter attaches to the dialyzer.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.The actual defective device is valuable tool in investigating the cause of this incident.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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).A review of the manufacturing records for sl-2000m2095 lot # 30155005 was performed and indicated there were no quality issues during the manufacturing of this lot.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.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; bethelehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethelehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17948476
• MDR Text Key: 325803694
• Report Number: 2521402-2023-00257
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SL-2000M2095
• Device Lot Number: 30155005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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