MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC.; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/04/2023

Event Type  malfunction  

Event Description

During a critical part of anesthesia delivery (laryngospasm during an egd), the iv tubing broke clear in half in the middle of the tubing where it is connected right above the hub.It was a very dire situation that required rescue meds to be administered emergently.Thankfully we had enough help to fix the situation before any harm could occur to the patient.However, the entire ivf tubing needed to be replaced, the infusion of propofol needed to be stopped briefly, blood was backing up into the tubing.Broken tubing was saved and given to management.Manufacturer response for iv tubing, iv tubing (per site reporter) ongoing issue with manufacturer.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16157194
• MDR Text Key: 307293798
• Report Number: 16157194
• Device Sequence Number: 1
• Product Code: FPA
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1