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 07/09/2021

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: a bug was found inside the line of the bloodline set.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 returned for evaluation and a picture was also provided.The complaint was confirmed when the set and photograph were visually inspected, finding a bug in the venous line.Additional photographs of the set were taken and provided to manufacturing for review.Manufacturing was unable to determine the root cause of this issue based on the available information.A review of the device history records for sl-2010m2096 from lot 10354010 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
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 824 12th avenue; bethlehem PA 18018 0027
• MDR Report Key: 12188144
• MDR Text Key: 262193958
• Report Number: 2521402-2021-00049
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: SL-2010M2096
• Device Catalogue Number: SL-2010M2096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Manufacturer Received: 07/09/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 07/09/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1