MAUDE Adverse Event Report: B. BRAUN MEDICAL INC.; CONTAINER, I.V.

Model Number 73295

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

A-line tubing connected to 500 ns and the new bags are having a problem with the rubber stopper coming off of the other port on the bags.This has happened to multiple patients and multiple nurses have reported having this issue with the new ns bags that are in stock.The bag is intact but the a-line can be lost without the pressure bag working properly.So, loss of a-line, risk for infection due to having to stick the pt again for a new a line plus we use the a-line to get labs then the pt will have more sticks for labs.

• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 16853027
• MDR Text Key: 314379455
• Report Number: 16853027
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 73295
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1