MAUDE Adverse Event Report: BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 227-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pulmonary Dysfunction (2019)

Event Date 11/11/2020

Event Type  Injury  

Manufacturer Narrative

A piece of the sample was returned and is being process for evaluation.The device history record for lot m18170t302 was reviewed and the product was produced according to product specifications.All information reasonably known as of 02 dec 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).

Event Description

It was reported that the patient's state of health began to deteriorate.An acute bronchoscopy was performed, and a foreign body was removed from the lungs.The foreign body is alleged to be from the valve flap of the closed suction catheter system.Additional information has been requested but not yet received.

Manufacturer Narrative

The sample returned consisted only of the flapper valve material that was detached from the assembly.The rest of the closed suction catheter was not returned.The material of the flapper valve was wrinkled in appearance with some cracking on the component.Attempts were made to reproduce this effect during manufacturing; however, the condition of the returned sample was unable to be duplicated.The complaint was confirmed as reported, however, no root cause could be determined.All information reasonably known as of 30 mar 2021 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 TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10967765
• MDR Text Key: 220190026
• Report Number: 8030647-2020-00101
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038989655
• UDI-Public: 00609038989655
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 227-5
• Device Catalogue Number: N/A
• Device Lot Number: M18170T302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 76