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

Model Number	6512
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Distress (2329)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter discarded the involved product, however, lot information for review.Production history records for the reported lot were reviewed.All in-process quality checks indicated passing results.A labeling review of the finished good was performed.The instructions for use state, "use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use.If not, remove any particles from oral cavity." the reporter stated the patient has a brain injury, and a bite block was not used.The review of the label is adequate for the intended use of the device and did not contribute to the reported failure.The root cause could be attributed to user error related to biting and not using a bite block during use of the product.Due to the review of the labeling and the product history and manufacturing records, there is insufficient evidence to conclude the reported issue was not attributable to a quality defect, or manufacturing operations.
Event or Problem Description
Report received of a user error resulting in a suction oral swab disengagement.Reporter, lay person, stated she performed oral care on her (b)(6) year old son who suffers from a traumatic brain injury and was unable to follow commands.Reporter stated her son bit down on the stick of the suction oral swab and a piece of the stick with attached foam broke off, and became disengaged inside her sons throat.Reporter stated she called 911 because her son was in distress.Reporter stated it took her husband approximately 2 minutes to successfully retrieve the piece of suction oral swab with attached foam.Reporter stated the paramedics arrived at that time and no treatment was needed or provided.The reported issue occurred during initial use of the device.Instructions for use state, a bite block should be used when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Reporter stated that although the patient was unable to follow commands, a bite block was not used at the time of the incident.The device was discarded, however, lot information was provided.Though requested, no additional information was provided.

• Brand Name: TOC SOS W/PROX 100
• Common Device Name: SUCTION ORAL SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 11004321
• Report Number: 0001419181-2020-00002
• Device Sequence Number: 690558
• Product Code: JOL
• UDI-Device Identifier: 50618029800638
• UDI-Public: 50618029800638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/08/2022
• Device Model Number: 6512
• Device Catalogue Number: 6512
• Device Lot Number: 76516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR