MAUDE Adverse Event Report: SAGE PRODUCTS LLC INTL TOC SOB-1PK 100; SUCTION ORAL BRUSH

Catalog Number 6577-X

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

The involved device was not returned but a lot number was provided.Production history records were reviewed.All in-process quality checks indicated passing results.A labeling review of the finished good was performed.The instructions for use state "do not allow patient to bite down on the oral care tool.Use a bite block if patient has altered levels of consciousness or cannot comprehend commands.Use caution with children and unresponsive individuals.Failure to follow these safety precautions may damage the device and present a choking/aspiration hazard.May not function as intended/potential risk of cross-contamination if device is reused." the review of the label is adequate for the intended use of the device and did not contribute to the reported failure.No definitive root cause could be determined.Discarded by facility.

Event Description

Report received of a malfunction resulting in the foam of a suction oral brush disengagement.On an unspecified date, oral care was performed on a patient undergoing a sedation reduction.The report stated during oral care the foam from a suction oral brush disengaged and stayed in the patient¿s mouth.Report stated the foam was difficult to remove, however the facility did not provide additional details on what interventions were required.Involved device was discarded but product code and lot code were provided.Although requested, no additional information was provided.

• Brand Name: INTL TOC SOB-1PK 100
• Type of Device: SUCTION ORAL BRUSH
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer (Section G): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer Contact: susie hinkle ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 11555453
• MDR Text Key: 242786640
• Report Number: 0001419181-2021-00007
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2022
• Device Catalogue Number: 6577-X
• Device Lot Number: 75965
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2020
• 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