MAUDE Adverse Event Report: AVANOS MEDICAL INC. TURBO-CLEANING CLOSED SUCTION CATHETER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 227

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907); Suction Failure (4039)

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

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 10 feb 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.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

It was reported that the customer felt "like they are not getting adequate suction from the device to remove secretions optimally.There was one instance where the therapist had to straight catheter suction the patient to remove the secretions." no patient injury was reported.Additional information received 28-jan-2020 indicated "the.Catheter was not suctioning as they expected.The cap on saline flush port did not stay on.Pulling back the catheter was tighter than expected.".

• Brand Name: TURBO-CLEANING CLOSED SUCTION CATHETER
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 9705731
• MDR Text Key: 200658235
• Report Number: 8030647-2020-00009
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 227
• Device Catalogue Number: 109383902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2020
• 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