MAUDE Adverse Event Report: SAGE PRODUCTS LLC QCARE RX Q2 SYS W/CORINZ 10; SUCTION ORAL SWAB

Catalog Number	6962
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned to the facility for evaluation.Inspection showed a majority of the foam head had been disengaged.The tip of the straw was inside the disengaged foam.The suction oral swab has roughly a third of the foam still intact, confirming a presence of glue.Product history records were reviewed, all quality checks performed indicated passing results and all release criteria were met per the product drawing.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 reported complaint is not a quality or a manufacturing defect.The root cause of the reported complaint is most likely due to user error of patient biting the swab.
Event or Problem Description
Report received of a suction oral swab disengagement.The reporter stated the patient bit down on the suction oral swab causing the green foam to disengage inside the patient¿s mouth.The reporter stated that she was unaware if the patient was alert and oriented.The reported issue occurred during the initial use of device and no bite block was in use.Reporter stated the disengaged foam was successfully retrieved without difficulty and no injury occurred.The involved device was returned for evaluation.Although requested, no additional information was available.

• Brand Name: QCARE RX Q2 SYS W/CORINZ 10
• Common Device Name: SUCTION ORAL SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 11800988
• Report Number: 0001419181-2021-00008
• Device Sequence Number: 14223213
• Product Code: JOL
• UDI-Device Identifier: 50618029830765
• UDI-Public: 50618029830765
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: 05/16/2022
• Device Catalogue Number: 6962
• Device Lot Number: 80579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84