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	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Report received of suction swab disengagement.The reporter stated 2 small pieces of foam disengaged from the corners of the suction swab head.Reporter stated the event occurred with initial use of the swab to perform oral care for a 15-year-old female patient.Reporter stated oral care provided during this event, consisted of a 3-5 minute routine to clean and remove copious dry mucous and debris from the oral cavity using the affected device.The reporter stated the foam head did not disengage from the stick.A bite block was not in use.Per reporter, the patient has a chromosomal deletion disorder, misaligned jaw, and low muscle tone so she does not have the ability to bite down on the swab, and did not chew on or clamp down on the swab.The patient has all her teeth and has no broken teeth or sharp hardware in her mouth that would have caused the foam to disengage.The disengaged pieces were noted to be missing from the swab head after the oral care was performed, but they were not visualized or located.The patient did not experience any adverse consequences.Lot information was provided and the reporter returned sample product from the same lot for evaluation.No additional information was provided.
Additional Manufacturer Narrative
Lot information and unused sample devices from the same lot were provided to aid in the investigation.A visual/functional inspection was performed for the178 same lot sample swabs that were returned by the complainant.None of the swabs had visible damage, and there were no instances of foam being detached from the swab.All swabs appeared to meet release criteria per the product drawing.A product history review was performed for the components within the affected device¿s lot.Work orders for this lot were unrelated to the integrity of the foam.All quality checks performed indicated passing results and all release criteria were met per the product drawing.In process quality checks are performed every two (2) hours and could potentially identify defects with the components.A nonconformance was initiated on 10/21/2024 for manufacturability issues with the foam used with the suction swab component.The manufacturability issues include stoppages and jams on the machines.Stryker provided foam samples to the supplier for an investigation.The material was found to be within specifications and no issues were detected with the material.A labeling review was performed for finished good.The warning section 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.¿ additionally, the instructions for use state "instructions for use: clean teeth and mouth for 1 minute.Repeat cleaning with other swab as needed.Discard product after use." the affected swab with the foam disengagement was discarded by the complainant and could not be sent back.Therefore, the failure mode could not be confirmed, and a definitive root cause cannot be established.A nonconformance was opened as a result of a risk file threshold breach.Further investigation will be conducted through the nonconformance.
Event or Problem Description
No additional event information has been received.

• 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: 22150189
• Report Number: 0001419181-2025-00012
• Device Sequence Number: 7811931
• Product Code: JOL
• UDI-Device Identifier: 00618029800633
• UDI-Public: (01)00618029800633(11)250411(17)270209(10)102707
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/13/2025

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: 102707
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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: 15 YR
• Patient Sex: Female