MAUDE Adverse Event Report: AVANOS MEDICAL, INC. BALLARD; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Lot Number 30232113

Device Problems Delivered as Unsterile Product (1421); Material Split, Cut or Torn (4008)

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

Event Date 04/19/2023

Event Type  malfunction  

Event Description

Ett ballard closed suction catheter sleeve was ripped on inspection, becoming nonsterile.

• Brand Name: BALLARD
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16960719
• MDR Text Key: 315541311
• Report Number: 16960719
• Device Sequence Number: 1
• Product Code: BSY
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 30232113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1