MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC SOS W/PROX 100; SUCTION SWAB

Model Number	6512
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report received of a suction swab disengagement.Reporter stated he was using a suction swab while performing oral care without a bite block in place on his son.A piece of the swab became detached from the device during initial use of the device.Reporter stated his son has a tracheostomy and cannot follow commands due to a traumatic brain injury (tbi).Reporter stated his son has no oral hardware and did not bite the device.Reporter stated he did not use excessive force while performing oral care.The reporter stated he was able to retrieve the piece from his son¿s mouth with his fingers.The patient did not experience any adverse outcomes.No photos of the device are available, and the device has been discarded.Lot information was provided.Although requested, no sample product was returned for evaluation.
Additional Manufacturer Narrative
Lot information was provided to aid in the investigation.However, affected material was not returned, nor were any photographs provided.Therefore, no visual or functional inspection could occur.A product history review was performed.All quality checks performed indicated passing results and all release criteria were met per the product drawing.A labeling review was performed.The product label states "ensure foam on swab is intact before and after use.Remove any foam particles from mouth.Always use a bite block if patient is not alert or cannot follow instructions.Single use only, for oral care.Do not reuse or clean for reuse." a bite block was not in use during the event; however, it was reported that the patient did not bite.Additionally, 100% of the swabs undergo a swab head pull test to verify the foam is securely attached to the stick and any of the swabs that fail the swab head pull tester would be rejected.The root cause of the detached swab head cannot be confirmed.

• Brand Name: TOC SOS W/PROX 100
• Common Device Name: SUCTION SWAB
• 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: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 21213588
• Report Number: 0001419181-2025-00001
• Device Sequence Number: 18288536
• Product Code: JOL
• UDI-Device Identifier: 50618029800638
• UDI-Public: (01)50618029800638(11)241126(17)261020(10)100721
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6512
• Device Catalogue Number: 6512
• Device Lot Number: 100721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male