MAUDE Adverse Event Report: SAGE PRODUCTS LLC INTL QCARE RX Q4 SYS W/CORINZ; SUCTION ORAL TOOTHBRUSH

Catalog Number 6964-X

Device Problem Material Separation (1562)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

Report received of a suction oral brush disengagement.Report stated a 62 year old, male patient weighing 65kg bit down on the shaft of the suction oral brush while oral care was being performed.Patient was receiving end of life care at the time the event occurred.The patient had an altered level of consciousness with a glascow coma score of 7-9.The patient bit down on the shaft of the device and caused a full and clean break through the plastic and the suction oral brush head disengaged from the shaft.The patient experienced a desaturation in his oxygen level.The oxygen being provided to the patient was increased.After 10 minutes the patient appeared comfortable and comfort care was resumed.At an unspecified time, video laryngoscope was performed to visualize the upper airways and a chest x-ray was completed; however, the disengaged suction oral brush head was not visualized during either procedure.Staff concluded that the disengaged suction oral brush head was swallowed by the patient.Staff declined performing a bronchoscopy due to the fact the patient appeared more comfortable and they did not want to put the patient through any unnecessary procedures.No bite block was in use at the time this event took place.The nurse was not aware whether the patient had a history of biting during oral care.The patient subsequently passed away 6 hours following the event, however, the reporter concluded that the suction oral brush head disengagement did not cause or contribute to the patient's death.Although requested no additional information is available.

Manufacturer Narrative

Involved device was discarded by facility and no photos were available of the involved device.Facility was not able to confirm the lot number of the involved device, however provided 7 lot numbers (85871, 85116, 85593, 84870, 84264, 83587, 83330) that were sent to them over the last 6 months.Product history records were reviewed, all quality checks performed indicated passing results and all release criteria were met per product drawing.A labeling review of the finished good was performed.The instructions for use state ¿do not allow patient to bite down on the oral care tool.Use a bite block if patient has altered levels of consciousness or cannot comprehend commands.Use caution with children and unresponsive individuals.Failure to follow these safety precautions may damage the device and present choking/aspiration hazard.¿ the suction oral brush was confirmed to be manufactured to specifications.The health professional using the suction oral brush did not follow the instructions on the outer bag label which cautioned the user to use a bite block and do not allow the patient to bite down on the suction oral brush.Discarded by facility.

• Brand Name: INTL QCARE RX Q4 SYS W/CORINZ
• Type of Device: SUCTION ORAL TOOTHBRUSH
• 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: susie hinkle ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 15316574
• MDR Text Key: 303245331
• Report Number: 0001419181-2022-00005
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6964-X
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 65 KG