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

Model Number	6994
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved device was not returned, photographs of the affected device were not provided, and the lot number was not identified.Therefore, a visual/functional inspection could not be performed.It was alleged by the complainant that a disoriented patient bit down on the suction swab stick directly underneath the foam resulting in the stick separating into two pieces.Although the reporter stated the patient was disoriented, a bite block was not in use at the time of the event.There is a warning statement on the package which states "ensure foam on swab is intact before and after use.Remove any foam particles from mouth.Always use a bite block if patient is not alert or cannot follow instructions." the reported complaint is not likely to be a quality or a manufacturing defect.The root cause is due to user error.H3 other text : device involved in incident discarded.
Event or Problem Description
Report received of a suction swab disengagement that occurred on (b)(6) 2024.Reporter stated a nurse was performing oral care without a bite block in place on a disoriented 52-year-old male patient who was ventilated through a tracheostomy.The patient bit down on the suction swab contained in #6994 oral cleansing and suctioning system.Reporter stated the patient bit down on the swab stick directly underneath the foam.The stick separated in two pieces and the portion of the stick with the swab head, remained in the patient¿s mouth.Two nurses then coached the patient to open his mouth, and they were able to remove the portion of the stick with the swab head from the patient¿s mouth with their fingers.The patient did not experience any adverse consequences.The swab was discarded.Lot information is not available.No photos are available.Although requested, no other information was available.
Additional Manufacturer Narrative
It was discovered that this report as it was previously submitted, did not contain the correct device codes.This report is being resubmitted with the correct device codes.There have not been any new investigation findings since the initial mdr submission on 03/19/2024.
Event or Problem Description
No additional event information has been received.

• Brand Name: QCARE Q4 CORINZ SYS W/THUMBPOR
• Common Device Name: SUCTION ORAL SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer (Section G): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• Manufacturer Contact: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 18936398
• Report Number: 0001419181-2024-00002
• Device Sequence Number: 12523402
• Product Code: JOL
• UDI-Device Identifier: 50618029830949
• UDI-Public: 50618029830949
• 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,Followup
• Report Date (Section B): 03/17/2025

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: 6994
• Device Catalogue Number: 6994
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male