MAUDE Adverse Event Report: AVANOS MEDICAL, INC. BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number 93896

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 07/08/2021

Event Type  malfunction  

Event Description

This inline suction catheter broke off in the patient's endotracheal tube, presenting an airway emergency.The piece of the suction tube that is inserted into the ett is what broke, it broke off inside of the ett.We were able to resolve the issue with no ill effect to the patient, who was able to breathe on his own during the event.However, during this event the patient was disconnected from the ventilator and we did not have a way to bag him.The situation was resolved without harm to the patient.

• Brand Name: BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12158035
• MDR Text Key: 261274065
• Report Number: 12158035
• 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
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 93896
• Device Catalogue Number: 1912
• Device Lot Number: M18150T508
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2021
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2555 DA
• Patient Weight: 27