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

Catalog Number SL-2000M2095

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Air/Gas in Device (4062)

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

Event Date 03/13/2024

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: good morning, i would like to report an incident where we found a defected blood line.Incident date : (b)(6) 2024.Pt initial: (b)(6).Bloodline: lot # a2300943.Product # sl-2000m2095.Exp: 08/07/2026.Report: patient machine alarming ,air detected during hd tx staff noticed that micro air bubbles on the top of dialyzer header and in venous chamber, upon inspection clinical practitioner found a few drops of blood at the blood pump roller track.Treatment was terminated.Upon inspection of the blood line, we found tiny pinched/cut like damage right above the arterial pod of the bloodline.No injury reported.

• 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
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18948577
• MDR Text Key: 338781217
• Report Number: 2521402-2024-00040
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: A2300943
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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