MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A

Model Number SL-2010M2096

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/18/2022

Event Type  malfunction  

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.

Event Description

As reported by the user facility: the venous line tubing detached from the blue dialyzer connector.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The sample and all available information were forwarded to the supplier for further evaluation.Based on the investigation results, the complaint could not be confirmed with the returned set during visual inspection as all luers were properly connected to the tubing.A photograph of the tubing set was also provided for evaluation.The complaint was confirmed as the connector on the venous line was detached from the tubing.The root cause of this issue could not be determined based on the available information.A review of the device history records for (b)(4) lot 20254001 were 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 blood tubing set lot number shows no additional complaints of component disconnections as of complaint closure, indicating this is an isolated occurrence.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 14594961
• MDR Text Key: 301992610
• Report Number: 2521402-2022-00033
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367786
• UDI-Public: (01)04046964367786
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

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 Model Number: SL-2010M2096
• Device Catalogue Number: SL-2010M2096
• Device Lot Number: 20254001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 07/27/2022
• 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: Initial
• Patient Sequence Number: 1