MAUDE Adverse Event Report: CAREFUSION 2200, INC. V. MUELLER; CATHETER AND TIP, SUCTION

Device Problems Material Too Rigid or Stiff (1544); Material Deformation (2976)

Patient Problem Laceration(s) (1946)

Event Date 10/16/2020

Event Type  malfunction  

Event Description

The v.Mueller frazier suction tube had a barb on the tip and tore the dura.

• Brand Name: V. MUELLER
• Type of Device: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 11139123
• MDR Text Key: 225807533
• Report Number: 11139123
• Device Sequence Number: 1
• Product Code: JOL
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2021
• Date Report to Manufacturer: 01/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21900 DA