MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BLOOD ADMINISTRATION SET; SET, BLOOD TRANSFUSION

Model Number V2400

Device Problems Break (1069); Separation Failure (2547); Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2021

Event Type  malfunction  

Event Description

First bag of stem cells infused to red lumen of patients triple lumen central venous catheter left internal jugular vein.Attempted to detach luer lock stem cell blood set tubing from lumen and luer lock would not release.Multiple nurses attempted to detach tubing from catheter and would not release.Rubber tourniquets utilized and would not release.Hemostat utilized and tubing released from catheter hub.Upon assessment found protruding plastic piece from stem cell tubing broken off in the hub of the catheter.Carter rep at bedside and aware.Dr notified and assessed patient.Catheter hub cleaned per protocol, hemodialysis white curos cap placed to end of catheter hub, catheter remained clamped, and line marked not to use.Stem cell tubing placed in biohazard bag at bedside to return to carter to return to company to investigate.

• Brand Name: BLOOD ADMINISTRATION SET
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 13357758
• MDR Text Key: 284455878
• Report Number: 13357758
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

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 Model Number: V2400
• Device Catalogue Number: V2400
• Device Lot Number: 0061777868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16425 DA
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Race: Black Or African American