MAUDE Adverse Event Report: HEMODIALYSIS BLOODLINES; BLOOD TUBING SETS

Model Number SL-2000M2095D

Device Problem Leak/Splash (1354)

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

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 the distributor from their end customer: blood is leaking from the dialyzer.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, an unopened case of this blood tubing set's lot number was provided for evaluation.The complaint could not be confirmed with any of the unopened sets.A review of the device history records for sl-2000m2095d from lot 01255067 was performed and indicated that there were no quality issues during the manufacturing process of this lot related to the reported issue.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: BLOOD TUBING SETS
• MDR Report Key: 12188434
• MDR Text Key: 262193445
• Report Number: 2521402-2021-00051
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046955348763
• UDI-Public: (01)04046955348763
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

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: 12/15/2023
• Device Model Number: SL-2000M2095D
• Device Catalogue Number: SL-2000M2095D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1