MAUDE Adverse Event Report: AVANOS MEDICAL INC. CLOSED SUCTION SYSTEM FOR ADULTS, 12 F, DSE, WET PAK; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 216036-4J

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

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.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 15-jan-2019 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).

Event Description

Avanos medical received a single report that referenced three different incidents, which were associated with separate units, involving an unknown number of patients.This is the first of three reports.Refer to 8030647-2019-00009 for the second patient.Refer to 8030647-2019-00010 for the third patient.It was reported that the connection between the suction catheter and flex connector was loose and disconnected during the suction process.The suction catheter was replaced for a new one immediately with no patient injury.

Manufacturer Narrative

Avanos medical received one used suction catheter and one used flex connector.No product packaging was received.The received sample was evaluated and the reported event was confirmed.The root cause was attributed to a manufacturing related issue.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 11-feb-2019 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: CLOSED SUCTION SYSTEM FOR ADULTS, 12 F, DSE, WET PAK
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8257973
• MDR Text Key: 134712777
• Report Number: 8030647-2019-00008
• Device Sequence Number: 1
• Product Code: BSY
• 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
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

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: 08/02/2022
• Device Model Number: 216036-4J
• Device Catalogue Number: 109934907
• Device Lot Number: M7214L615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 02/12/2019
• Patient Sequence Number: 1