MAUDE Adverse Event Report: SAGE PRODUCTS LLC QCARE RX Q4 SYS W/CORINZ 20; COVERED YANKAUER

Catalog Number	6964
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Report received of a covered yankauer soft molded tip disengagement.The reporter did not have firsthand knowledge of the event; however, they provided the following details.Reportedly, a 77-year-old female patient was admitted on (b)(6) 2024 for altered mental status and respiratory distress.The patient was initially intubated at admission.The patient was extubated on (b)(6) 2024; however, the clinical decision was made to reintubate on (b)(6) 2024.Prior to intubation, the patient was suctioned with the covered yankauer.The patient was agitated, and a bite block was not in use.The patient reportedly, would frequently bite down on products inserted into the oral cavity; however, biting could not be confirmed by the reporter at the time of the disengagement.The yankauer tip disengagement was not initially noted; however, shortly after the patient was suctioned, a provider opened the oral cavity to intubate and observed the soft molded tip from the yankauer in the patient's throat.The provider was able to remove the yankauer tip with their fingers.The patient did not experience any adverse consequences.Although the affected device was discarded, lot information and photos of the affected device were provided.
Event or Problem Description
Report received of a covered yankauer soft molded tip disengagement.The reporter did not have firsthand knowledge of the event; however, they provided the following details.Reportedly, a 77-year-old female patient was admitted on (b)(6) 2024 for altered mental status and respiratory distress.The patient was initially intubated at admission.The patient was extubated on (b)(6) 2024; however, the clinical decision was made to reintubate on (b)(6) 2024.Prior to intubation, the patient was suctioned with the covered yankauer.The patient was agitated, and a bite block was not in use.The patient reportedly, would frequently bite down on products inserted into the oral cavity; however, biting could not be confirmed by the reporter at the time of the disengagement.The yankauer tip disengagement was not initially noted; however, shortly after the patient was suctioned, a provider opened the oral cavity to intubate and observed the soft molded tip from the yankauer in the patient's throat.The provider was able to remove the yankauer tip with their fingers.The patient did not experience any adverse consequences.Although the affected device was discarded, lot information and photos of the affected device were provided.
Additional Manufacturer Narrative
The affected device was discarded.However, a photograph of the affected device was provided.A visual inspection was performed on the photograph of the affected product.The photograph shows the yankauer component with the sleeve retracted and the soft tip overmold completely detached from the yankauer straw.The yankauer straw appears to show evidence of where the soft tip was over molded and melted onto the hard straw indicating that the product was manufactured correctly.A product history review was performed for the implicated product code, lot number and affected components.All in-process quality checks performed during the manufacturing process indicated passing results and all release criteria were met per the product drawing.The soft tip overmold is manufactured at a third-party supplier.The supplier¿s production records indicated the product was manufactured to specifications and a retains force test found zero failing parts.A labeling review was performed.The instructions for the yankauer state "always use a bite block if patient is not alert or cannot follow instructions¿.Although it was not confirmed that the patient bit the yankauer component, a bite block should have been in use.Therefore, the instructions were not followed.The root cause for this event could not be identified.

• Brand Name: QCARE RX Q4 SYS W/CORINZ 20
• Common Device Name: COVERED YANKAUER
• 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: 20216783
• Report Number: 0001419181-2024-00009
• Device Sequence Number: 12699152
• Product Code: JOL
• UDI-Device Identifier: 00618029830753
• UDI-Public: (01)00618029830753(11)240308(17)250804(10)96849
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 08/04/2025
• Device Catalogue Number: 6964
• Device Lot Number: 96849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/08/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 77 YR
• Patient Sex: Female