MAUDE Adverse Event Report: LIBERATOR CS, CSS W MFD, 14 FR; VAP CLOSED SUCSTION CATHETERS & ACCESSORIES

Model Number 01-EC-459-1401

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2021

Event Type  malfunction  

Manufacturer Narrative

The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.A review of the device history record is in-progress.All information reasonably known as of 04-feb-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 four different incidences, which were associated with separate units, involving four different events.This is the third of four reports.Refer to 3011270181-2021-00001 for the first event.Refer to 3011270181-2021-00002 for the second event.Refer to 3011270181-2021-00004 for the fourth event.It was reported the closed suction catheter (csc) was "leaking secretions" near the thumb-port of the csc after suctioning of the patient.Additional information received 13-jan-2021 stated the csc was placed on the patient friday, (b)(6) and the signs of leakage was discovered the saturday, (b)(6).There was no reported injury.

Manufacturer Narrative

The device history record for the reported lot number, 20062301, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 24-jun-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, 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: LIBERATOR CS, CSS W MFD, 14 FR
• Type of Device: VAP CLOSED SUCSTION CATHETERS & ACCESSORIES
• MDR Report Key: 11282823
• MDR Text Key: 250324216
• Report Number: 3011270181-2021-00003
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-EC-459-1401
• Device Catalogue Number: N/A
• Device Lot Number: 20062301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1