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

Model Number	6904
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter discarded the involved product and did not provide photographs or lot information.Production history records could not be reviewed.The reporter stated most of the foam remained adhered on the suction oral swab straw.This indicates glue coverage was present.The reporter confirmed the patient was orally intubated, sedated and a bite block was not in use.Reporter did not know if biting occurred.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.Without the returned product, photographs, or further information, a definitive root cause could not be determined.There is insufficient evidence to conclude that the reported issue could be attributable to a product defect or manufacturing operations.Discarded by facility.
Event or Problem Description
Report received of a malfunction resulting in a suction oral swab foam disengagement.On (b)(6) 2019, oral care was performed on a patient.The reporter stated part of the green foam disengaged while in the patient's mouth.Reporter stated the disengaged foam was successfully retrieved and no injury occurred.Reporter stated patient was orally intubated and sedated, however, the reporter did not know if biting occurred.Reporter stated most of the green foam remained adhered to the suction straw.The device was discarded and no pictures were available.Lot information was not provided.Although requested, no additional information was available.

• Brand Name: QCARE RX Q4 SYS 20
• Common Device Name: SUCTION ORAL SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 8875932
• Report Number: 0001419181-2019-00008
• Device Sequence Number: 19489161
• Product Code: JOL
• UDI-Device Identifier: 50618029830086
• UDI-Public: 50618029830086
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 08/08/2019

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: 6904
• Device Catalogue Number: 6904
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1