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	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Uf/importer report# (b)(4).Discarded by facility.
Event or Problem Description
Received medsun report from fda.Per report, "while using sage kit for mouth care on ventilator, the swab broke off into patients mouth.I reached into his mouth to remove the swab.No harm to patient." report ref# (b)(4).Attempting to contact reporter to gather additional details.
Event or Problem Description
Received medsun report from fda.Per report, "while using sage kit for mouth care on ventilator, the swab broke off into patients mouth.I reached into his mouth to remove the swab.No harm to patient." report ref# (b)(4).After multiple attempts to obtain additional details regarding the reported issue of suction oral swab disengagement, no further information obtained.
Additional Manufacturer Narrative
Reporting facility did not provide return product, photographs or lot information.Production history records could not be reviewed.Per medwatch report ref# (b)(4), the report confirmed the patient was ventilated, however, it is unknown if the patient was alert and able to follow commands or if a bite block was in use.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.
Additional Manufacturer Narrative
Reporting facility did not provide return product, photographs or lot information.Production history records could not be reviewed.The reporter confirmed the patient was ventilated, unable to follow commands and no bite block was in use.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 a review of the reporter's information and a review of the product labeling, there is insufficient evidence to conclude that the reported issue could be attributable to a product defect or manufacturing operations.
Event or Problem Description
Received medsun report from fda.Per report, "while using sage kit for mouth care on ventilator, the swab broke off into patients mouth.I reached into his mouth to remove the swab.No harm to patient." report ref# (b)(4).After multiple attempts to obtain additional details regarding the reported issue of suction oral swab disengagement, no further information obtained.On 09/06/19, received additional information from the reporter.Report received of a malfunction resulting in a suction oral swab disengagement.On an unknown date, oral care was performed by a nurse on a patient who was ventilated and unable to follow commands.The reporter stated the patient bit down on the suction oral swab and the suction swab stick and green foam disengaged inside the patient's mouth.Reporter stated the disengaged foam was successfully retrieved and no injury occurred.The reported issue occurred during initial use of the device and no bite block was in use.The device was discarded and no pictures were available.Lot information was not 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: 8852473
• Report Number: 0001419181-2019-00007
• Device Sequence Number: 259871
• Product Code: JOL
• UDI-Device Identifier: 50618029830772
• UDI-Public: 50618029830772
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2019

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
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019; 07/12/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 08/15/2019; 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR