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 02/19/2024

Event Type  malfunction  

Event Description

Event 2 as reported by the user facility: per customer email to cardinal: yesterday our dci lafayette clinic experienced multiple bloodlines with holes in them on the blood pump portion of the line.They have saved 2 of the lines that were used if you need them.Upon inspection of other lines in this same lot they found many more.Per email attachment: air noticed in line with blood leaking around blood pump.Patients rinsed back as much as safely possible.After removing blood lines a tear in the line was visible.This happened again with another patient.After the second incident all lines with the lot # 230118 was pulled from floor.Upone examining some of the pulled lines 6 other lines were noticed to have 'tears' in the blood pump portion of line.No injury reported.

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.

• 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 ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18837646
• MDR Text Key: 337775483
• Report Number: 2521402-2024-00032
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• 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: A2301118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2023
• 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