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

Model Number SL-2010M2096A

Device Problems Loose or Intermittent Connection (1371); Air/Gas in Device (4062)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  malfunction  

Event Description

As reported by the user facility: event 9: "i've been having problems with the streamlines when it's time to return patients.When we connect the arterial line to the saline line, the lines sucks air.You have to either keep screwing it on and off for it not to suck or screw it on really tight.It's like a seal in the saline line that's keep the saline from moving through the lines.No patients were injured as a result, but some blood lost due to clotting from air getting in lines.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400602740.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

Event 9: this report has been identified as b.Braun medical internal report number (b)(4).Fourteen (14) unused samples in original packages were returned for evaluation.Samples were visually evaluated, and no defects were observed.All samples were occlusion and leak tested with passing results.In addition, all samples were attached to a water line, and all locksites were tested by pushing and pulling fluid through a syringe, and on all fourteen samples, the fluid freely flows through the line.Based on the evaluation results, the defect was not confirmed.The product met internal specifications.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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 DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17083131
• MDR Text Key: 316858085
• Report Number: 2523676-2023-00275
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046955674992
• UDI-Public: (01)04046955674992
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2010M2096A
• Device Catalogue Number: SL-2010M2096A
• Device Lot Number: 0061847732
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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