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

Model Number SL-2000M2095

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

As reported by user facility: event 2: droplets of blood were noted when inspected by staff.It was found that the bloodline had a separation from the line itself at the arterial connector.No injuries were reported.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 2.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

Event 2: this report has been identified as b.Braun medical internal report number (b)(4).Several samples and a photo were provided for evaluation.The sets were visually evaluated for any cracking/breaking issues with no defect observed.However, the photo provided was visually evaluated and the set was observed to be detached.Based on the evaluation results, the reported defect was confirmed via the photo.The potential root cause was determined to be due to excessive solvent.Due to issues of this nature an assembly technique procedure was created to specify the correct solvent application.All personnel involved in the manufacturing process have been trained to the assembly technique to prevent recurrence.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: BLOOD TUBING SETS
• 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12954424
• MDR Text Key: 281870562
• Report Number: 2521402-2021-00090
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367762
• UDI-Public: (01)04046964367762
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2000M2095
• Device Catalogue Number: SL-2000M2095
• Device Lot Number: A2100419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2021
• 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: Initial
• Patient Sequence Number: 1