MAUDE Adverse Event Report: AVANOS MEDICAL SALES / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) BALLARD MULTI-ACCESS CATHETER; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number 1920

Device Problems Defective Component (2292); Obstruction of Flow (2423)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

Intubated neonate required administration of surfactant.Nurse and respiratory therapist unable to administer the medication through the opening in the y-piece of the attachment.Y-piece with suction catheter attached to endotracheal tube was noted to have a defect, not allowing a suction catheter or medication to pass into the tube.The respiratory therapist was able to change the y-piece with one that did not have the defect and administer the surfactant.No harm to patient.

• Brand Name: BALLARD MULTI-ACCESS CATHETER
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL SALES / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 16502724
• MDR Text Key: 310980505
• Report Number: MW5115525
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1920
• Device Lot Number: 30193655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White