MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) BALLARD MINI-BAL SAMPLING CATHETER; TRAY, SURGICAL, ENT

Lot Number 30111533

Device Problem Entrapment of Device (1212)

Patient Problem Bradycardia (1751)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

Pt was ordered mini bal to r side.Followed procedure guidelines, 100% fio2 sxn prior, turn suction pressure down to 60.Advanced mini bal catheter inside pt ett, till numbers matched.Advancing inner catheter with inspiration.During instillation 30ml of saline was advanced to r side, turned stopcock with no returned sputum, extra pressure noted.Pt started to brady to 51.Volumes on ventilator not returning.Immediately withdrew ett, allowing pt to recover.During this time with catheter withdrawn noted tip of catheter missing.Found missing catheter tip pulled back into catheter.Fda safety report id# (b)(4).

• Brand Name: BALLARD MINI-BAL SAMPLING CATHETER
• Type of Device: TRAY, SURGICAL, ENT
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ; alpharetta GA 30004
• MDR Report Key: 12392259
• MDR Text Key: 269425308
• Report Number: MW5103608
• Device Sequence Number: 1
• Product Code: MMO
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Lot Number: 30111533
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR