MAUDE Adverse Event Report: AVANOS MEDICAL INC. RESTORE2 - ENDOTRACHEAL TUBE CLEANER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 01-EC-350-0001

Device Problem Break (1069)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

It was reported, the attending md was using the endotracheal tube cleaning system and the catheter snapped off in the endotracheal tube.The patient desaturated.The md was able to retrieve the snapped piece from the endotracheal tube.No injury or medical interventions reported.Per additional information received on 11 sept 2023, the patient had a size 7.5mm endotracheal tube.No harm occurred to the patient.

Manufacturer Narrative

The product involved in the report has been returned and the investigation remains in progress at this time.A review of the device history record is in-progress.All information reasonably known as of 19 sep 2023 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 reported event but is relaying the information 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.

Manufacturer Narrative

4247: investigation findings: malfunction observed without conclusive finding.The device history record for lot 9447802 could not be reviewed.The actual sample from the reported event was returned for evaluation.Visual examination of the device: the catheter appeared detached, (separated from the inner portion of the sleeve).The sleeve was pulled to access the collar component and the piece of the collar where the catheter was previously assembled.The end piece of the catheter and collar were put together and examined, they exhibited slight jagged edges to the separation/breaking points.The reported event could be confirmed as reported; however, the root cause is undetermined.All information reasonably known as of 1-apr-24 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 reported event but is relaying the information 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: RESTORE2 - ENDOTRACHEAL TUBE CLEANER
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): PRO-TECH DESIGN & MFG., INC.; 14561 marquardt ave.; santa fe springs CA 90670
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 17777424
• MDR Text Key: 323821683
• Report Number: 3011270181-2023-00120
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-EC-350-0001
• Device Catalogue Number: N/A
• Device Lot Number: 9447802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7.5MM ENDOTRACHEAL TUBE