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

Model Number SL-2000M2095

Device Problem Leak/Splash (1354)

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

Event Date 07/07/2021

Event Type  malfunction  

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.

Event Description

As reported by user facility: at the start of treatment blood leaked at the top of the venous chamber.The blood was not returned to the patient.The patient received antibiotics prophylactically post dialysis.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).All information associated with this event was submitted to the bloodline manufacturer.According to the manufacturer investigation, the blood tubing set was not returned for evaluation.The manufacturer initiated a quality alert to notify their personnel of the failure mode reported by the customer.A review of the device history records for sl-2000m2095 from lot a2100201 was performed and indicated there were no non-conformances, deviations, or exceptions during the manufacturing process of this lot related to the reported issue and all testing and product inspections were documented in compliance.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: BLOOD TUBING SETS
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 824 12th avenue; bethlehem PA 18018 0027
• MDR Report Key: 12188265
• MDR Text Key: 262186086
• Report Number: 2521402-2021-00050
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367762
• UDI-Public: (01)04046964367762
• Combination Product (y/n): N
• PMA/PMN Number: K080807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: SL-2000M2095
• Device Catalogue Number: SL-2000M2095
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1