MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 8 F, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 198-5

Device Problem Retraction Problem (1536)

Patient Problem Respiratory Distress (2045)

Event Date 07/05/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is not possible as a valid avanos lot number was not provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 23 sep 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 inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to (b)(4), 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.Device not returned.

Event Description

It was reported that a pediatric patient with "flexible tube was suctioned and tube care was executed.Child was ventilated when minute volume and tidal volume decreased drastically." both lungs were ventilated with good acoustic signs and spo2 [oxygen saturation] was fine.Blood gas showed an increase in co2 [carbon dioxide] from 5kpa to 8.2kpa.Child experienced sudden decrease in ventilation.When the user disconnected the tube they realized that the suctioning catheter was still in the tube of the patient and not fully retracted.Additional information provided 04-sep-2020 indicated the patient's age wasn't available.The patient was stable after the adjustment of the catheter.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 8 F, Y-ADAPTER
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10586579
• MDR Text Key: 208548167
• Report Number: 8030647-2020-00082
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038983868
• UDI-Public: 00609038983868
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 198-5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention