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

Model Number SL-2010M2096

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as event 3 of b.Braun medical inc.Internal report number (b)(4).The device involved has not been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

Event 3: as reported by user facility: after rinseback was completed, sediment was noted in the venous line and chamber.No patient injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4) event 3.One (1) blood tubing set was received by the manufacturer for evaluation.The returned sample was visually inspected and small white particles were observed in the venous line from the venous chamber to the end of the line, confirming the reported issue.The manufacturer determined the most likely root cause of the particles was resin produced by the extrusion machinery.A review of the device history records for sl-2010m2096 lot (b)(6) was performed and indicated that there were no quality issues during the manufacturing process of this lot related to the reported issue.A search of the complaint database for this bloodline tubing lot number shows no additional reports of component contamination for this lot number indicating this is an isolated occurrence.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: 10983112
• MDR Text Key: 220697686
• Report Number: 2521402-2020-00013
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367786
• UDI-Public: (01)04046964367786
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: SL-2010M2096
• Device Catalogue Number: SL-2010M2096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Date Manufacturer Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1