MAUDE Adverse Event Report: B. BRAUN MEDICAL INC HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number SL-2010M2096

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/18/2020

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: when reinfusion blood to patient at the end of treatment sediment was noted in the venous bloodline.Patient was asymptomatic and no injuries reported.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 3.One (1) bloodline set was received by the manufacturer for evaluation in conjunction with this complaint.The blood set was visually inspected and appeared to have been rinsed as there was no sediment observed in the line.A review of the device history records for sl-2010m2096, lot 00754022 was performed and it indicated there were no quality issues during the manufacturing process of this lot related to the reported issue.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The reported defect could not be confirmed.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): B. BRAUN MEDICAL INC; 824 12th avenue; bethlehem PA 18018 0027
• MDR Report Key: 10950028
• MDR Text Key: 220690592
• Report Number: 2521402-2020-00010
• 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: 12/04/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1