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

Catalog Number	6964
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report received of a suction oral swab disengagement.Reporter stated on (b)(6) 2023, a suction oral swab device was in use on a 70-year-old female patient who was awake but cognitively impaired, had no teeth and had a tracheostomy, when the entire foam sponge from the suction swab disengaged from the stick.Reporter stated that a bite block was not in use at the time of the incident and the patient did not bite down on the device.The technician was able to remove the disengaged foam from the patient¿s mouth with her fingers.There was no adverse consequence or clinically relevant delay in treatment related to this event.The device related to this report was discarded by the user.The reporter stated that the lot number of the device used during this reported event was unknown.The customer returned product from two different lot numbers in stock at the time of the event for evaluation.Although requested, no other information was available.
Additional Manufacturer Narrative
The involved 6964 product was not returned, photographs were not provided, and the lot number was not identified.Two lots that were stored at the event location at the time of the reported event were provided (lots 89816 and 88773).One case from each of the provided lots (89816 and 88773) was returned to sage for evaluation.All one hundred and fifty-six (156) suction swabs returned within these cases were inspected, and the swab heads were pulled by hand.Zero (0) swabs heads detached during evaluation indicating the presence of glue.No defects were detected.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 packaging label includes the following instructions, ¿ensure foam is intact after use.If not, remove any particles from oral cavity.".The root cause of the reported complaint could not be determined.
Event or Problem Description
Report received of a suction oral swab disengagement.Reporter stated on (b)(6) 2023, a suction oral swab device was in use on a 70-year-old female patient who was awake but cognitively impaired, had no teeth and had a tracheostomy, when the entire foam sponge from the suction swab disengaged from the stick.Reporter stated that a bite block was not in use at the time of the incident and the patient did not bite down on the device.The technician was able to remove the disengaged foam from the patient¿s mouth with her fingers.There was no adverse consequence or clinically relevant delay in treatment related to this event.The device related to this report was discarded by the user.The reporter stated that the lot number of the device used during this reported event was unknown.The customer returned product from two different lot numbers in stock at the time of the event for evaluation.Although requested, no other information was available.
Additional Manufacturer Narrative
Udi-di was inadvertently omitted in previous submission.

• Brand Name: QCARE RX Q4 SYS W/CORINZ 20
• 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: susie hinkle ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 16948066
• Report Number: 0001419181-2023-00003
• Device Sequence Number: 6356384
• Product Code: JOL
• UDI-Device Identifier: 50618029830758
• UDI-Public: 50618029830758
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/30/2023

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: 12/11/2023
• Device Catalogue Number: 6964
• Device Lot Number: 89816/88773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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: 70 YR
• Patient Sex: Female