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

Model Number	6145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report received of a suction swab disengagement.On (b)(6) 2025, a registered nurse (rn) on a trauma burn intensive care unit (icu) was performing regularly scheduled oral care with a suction swab on a 76-year-old male patient weighing 66.4kg, who was intubated and sedated.Per the reporter, 5 pea-sized pieces of the foam from the suction swab became disengaged during initial use of the device.The reporter stated some foam remained on the stick.The disengaged pieces were removed immediately from the patient¿s mouth, by the patient¿s daughter with their fingers.The patient did not experience any adverse consequences.The reporter stated the device was used with gentle swabbing, and the patient was intubated and did not bite down on the device, nor did the device get caught on any oral hardware in the patient¿s mouth.Per the reporter, the affected device was discarded, and no photos were available.Lot information was provided.
Additional Manufacturer Narrative
The complainant did not provide photographs of the affected device and did not return the affected device; however, the lot number of the affected device was provided for the investigation.A product history review was performed.All quality checks performed indicated passing results and all release criteria were met per the product drawing.There were four (4) work orders generated for the affected lots that may be related to the foam/glue of the suction swabs.Work was performed for each of these work orders to resolve the issue and bring the machine back to running as intended.A labeling review was performed.The product label states, "instructions for use: "ensure foam on swabs 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." the complainant stated a bite block was not in use, but no biting occurred.The patient was slow to follow commands, but reportedly, ¿would eventually follow them." the device was not reused as this incident occurred on the initial use of the device.Therefore, it appears the labeling was followed.Additionally, immediately after the adhesive is dispensed into the swab head hole, a vision system camera inspects 100% of the swab holes to ensure the correct amount of glue was dispensed into the hole.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.Therefore, a definitive root cause could not be established.
Event or Problem Description
No additional event information has been received.

• Brand Name: TOC SOS W/CORINZ 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: 21439198
• Report Number: 0001419181-2025-00003
• Device Sequence Number: 17230652
• Product Code: JOL
• UDI-Device Identifier: 50618029821510
• UDI-Public: (01)50618029821510(11)240827(17)260113(10)99344
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2025

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: Health Professional
• Device Expiration Date: 01/13/2026
• Device Model Number: 6145
• Device Catalogue Number: 6145
• Device Lot Number: 99344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2024
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 66 KG