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 Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 29 may 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.This product incident is documented in the 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).

Event Description

Avanos medical inc.Received a single report that referenced 18 different incidences, which were associated with separate units, involving 18 different patients.This is the ninth of 18 reports.Refer to 3011270181-2020-00064 for the first report.Refer to 3011270181-2020-00065 for the second report.Refer to 3011270181-2020-00066 for the third report.Refer to 3011270181-2020-00067 for the fourth report.Refer to 3011270181-2020-00068 for the fifth report.Refer to 3011270181-2020-00069 for the sixth report.Refer to 3011270181-2020-00070 for the seventh report.Refer to 3011270181-2020-00071 for the eighth report.Refer to 3011270181-2020-00073 for the tenth report.Refer to 3011270181-2020-00074 for the eleventh report.Refer to 3011270181-2020-00075 for the twelfth report.Refer to 3011270181-2020-00076 for the thirteenth report.Refer to 3011270181-2020-00077 for the fourteenth report.Refer to 3011270181-2020-00078 for the fifteenth report.Refer to 3011270181-2020-00079 for the sixteenth report.Refer to 3011270181-2020-00080 for the seventeenth report.Refer to 3011270181-2020-00081 for the eighteenth report.It was reported that the heat and moisture exchanger (hme) attached to the end of the endotracheal tube (ett) and to the ventilator circuit disconnected during ventilation.There was no reported injury and the device was replaced.Additional information received 08-may-2020 included lot numbers and quantity of incidents.The user facility stated "for all of these lot numbers, they all seem too big on the opening for the circuit and the tube.They disconnect either during ventilation or just slide off when trying to attach them.".

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A potential root cause was identified and actions have been implemented.All information reasonably known as of (b)(6)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 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: 10102134
• MDR Text Key: 202247727
• Report Number: 3011270181-2020-00072
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 00609038938165
• UDI-Public: 00609038938165
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: 150
• Device Catalogue Number: 109381602
• Device Lot Number: 2019-06-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2020
• Patient Sequence Number: 1