MAUDE Adverse Event Report: SAGE PRODUCTS LLC QCARE Q4 SYS W/CORINZ 20; SUCTION ORAL SWAB

Model Number	6464
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter discarded the involved product, however, provided a photograph for review.Evaluation of photograph revealed one suction oral swab missing the green foam head.The suction oral swab straw appears to have biting indentations in the straw.Trace amounts of green foam can be seen left on the end of the suction oral swab straw.A physical evaluation of the product could not be performed because the product was discarded by the reporter.Production history records could not be reviewed.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 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 photograph and review of the labeling, there is insufficient evidence to conclude the reported issue was attributable to a quality defect or manufacturing operations.Discarded by facility; photographs provided.
Event or Problem Description
Report received of a malfunction resulting in a suction oral swab disengagement.Oral care was performed by a nurse on a patient who was unable to follow commands.The reporter stated the patient bit down on the suction oral swab straw causing the straw and green foam to disengage inside the patient's mouth.Reporter stated the disengaged straw and green foam were successfully retrieved and no injury occurred.The reported issue occurred during initial use of the device and no bite block was in use during the reported issue.The device was discarded, however, a photograph was available.No lot information was provided.Although requested, no additional information was available.

• Brand Name: QCARE Q4 SYS W/CORINZ 20
• Common Device Name: SUCTION ORAL SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 9294050
• Report Number: 0001419181-2019-00014
• Device Sequence Number: 11263225
• Product Code: JOL
• UDI-Device Identifier: 50618029830772
• UDI-Public: 50618029830772
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 11/07/2019

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 Model Number: 6464
• Device Catalogue Number: 6464
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1