MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD MULTI-ACCESS PORT CATHETER, DOUBLE SWIVEL Y, WET PAK; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 240146-5

Device Problem Decoupling (1145)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is in-progress.On march 11, 2020, the covid-19 outbreak was characterized as a pandemic by the world health organization (who).Healthcare workers caring for patients with covid-19 are at elevated risk of exposures, and therefore returned samples coming from facilities which may be treating patients with covid-19 have an elevated risk of carrying the coronavirus.In order to reduce the risk of infection and control spread of covid-19, no complaint samples will be requested for return or assessed at this time.All information reasonably known as of 31 mar 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported that the suction catheter disconnected from the endotracheal tube too easily.As the patient was being treated for covid-19, the device was not saved by the hospital.There was no injury to the patient.

Manufacturer Narrative

The device history record for lot ab9077u05 was reviewed and the product was produced according to product specifications.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 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 MULTI-ACCESS PORT CATHETER, DOUBLE SWIVEL Y, 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: 9930565
• MDR Text Key: 199074107
• Report Number: 8030647-2020-00029
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 240146-5
• Device Catalogue Number: N/A
• Device Lot Number: AB9077U05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Patient Sequence Number: 1