MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER; VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES

Model Number 150

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 09-dec-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

Avanos medical, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the second of two reports.Refer to 3011270181-2019-00073 for the first event.The small end of the integrated flex tube was too big for the patients endotracheal (et) tube and it slipped off due to a bad connection.There was no reported injury.Additional information received 21-nov-2019 stated the patient was intubated; as the clinicians went to put the heat moisture exchange (hme) on the et tube it would not stay and "popped off" as the clinicians began delivering gas during surgery.The device was replaced for a new device.There were no reported injuries.

Manufacturer Narrative

One used sample was received for evaluation.There was no obvious damage and the filter was found to be in place.The device history record for lot 2019-04-15 was reviewed and the product was produced according to product specifications.The root cause was determined to be supplier related.All information reasonably known as of 06 apr 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4) this information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: BALLARD 1500 FLEX HEAT AND MOISTURE EXCHANGER
• Type of Device: VAP AIRWAY CIRCUIT DRAINS, HME & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9449789
• MDR Text Key: 177232840
• Report Number: 3011270181-2019-00074
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 150
• Device Catalogue Number: 109381602
• Device Lot Number: 2019-04-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2020
• Patient Sequence Number: 1