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

Model Number 208

Device Problems Increase in Suction (1604); Tidal Volume Fluctuations (1634); Gas/Air Leak (2946)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

During patient care rn noticed patient etco2 suddenly low, tv on ventilator breaths very low, and patient with 99% leak.Trach placement checked and intact, patient with good breath sounds, patient saturations stable and patient pink.Etco2 monitoring device changed without change to etco2.Respiratory called to check vent and volume in cuff on trach.Respiratory inflated cuff to correct volume but no change in etco2, tv or leak.Attending md called to bedside and asked for trach to be changed.Trach changed with attending, fellow, and respiratory at bedside without adverse event, but etco2, tv and leak unchanged.Attending asked for vent and tubing to be changed.As vent was being set up, rt assessed in-line suction device and determined that it was not functioning properly, and patient was continuously getting suction applied to vent circuit.In-line suction device changed and etco2 returned to normal reading, tv and returned to 4-6cc/kg and leak was minimal 2-3%.Patient was stable throughout event.Similar reports in maude.Manufacturer response for in-line ventilator tubing in vap closed suction catheters & accessories, (brand not provided) (per site reporter) avanos acknowledged this complaint, sending rma and mailer.Avanos inquiry questions sent to.

• Brand Name: BALLARD
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 15326987
• MDR Text Key: 298963786
• Report Number: 15326987
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 208
• Device Lot Number: 30142956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other