MAUDE Adverse Event Report: SAGE PRODUCTS LLC QCOMP YANK SUCT HNDLE 40; COVERED YANKAUER

Model Number	6429
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the involved device nor samples from the same lot were returned, and photographs were not provided.Therefore, a visual/functional inspection could not be performed.Without lot information, a product history review could not be performed.The root cause of the soft molded tip disengagement could not be determined and therefore, no corrective actions were taken.Complaints relating to the soft molded tip disengagement will continue to be monitored and trended.
Event or Problem Description
Report received of a covered yankauer soft molded tip disengagement.The device was being used on a female patient with amyotrophic lateral sclerosis.Reporter stated the aide noted the patient¿s color had changed about 20 minutes after the patient was suctioned.The aide went to suction the patient again, and noted the tip of the yankauer was gone.The aide noted that the soft molded tip of the yankauer was in the patient¿s throat.Emergency medical service was contacted and worked on the patient to remove the disengaged tip.The reporter stated they had the two pieces of the device in their possession.However, despite several attempts to contact the reporter for follow up information and device return, no response was received.
Event or Problem Description
Report received of a covered yankauer soft molded tip disengagement.The device was being used on a female patient with amyotrophic lateral sclerosis.Reporter stated the aide noted the patient¿s color had changed about 20 minutes after the patient was suctioned.The aide went to suction the patient again, and noted the tip of the yankauer was gone.The aide noted that the soft molded tip of the yankauer was in the patient¿s throat.Emergency medical service was contacted and worked on the patient to remove the disengaged tip.The reporter stated they had the two pieces of the device in their possession.However, despite several attempts to contact the reporter for follow up information and device return, no response was received.
Additional Manufacturer Narrative
The homecare orders made by the complainant were able to be retrieved on 11/22/2024.The complainant made three (3) orders for product 6429 in which the lot numbers are 96773, 97239, and 97865.It is unable to be determined which lot this affected yankauer product came from, therefore, all three lots were investigated.A product history review was performed on all three lots which concluded that all quality checks performed indicated passing results and all release criteria were met per the product drawing.Additionally, the soft overmold of the yankauer device is manufactured at a third-party supplier and inspected at incoming quality assurance (iqa) at stryker cary prior to being used in the manufacturing process.Iqa inspections of the lots noted above, indicated passing results for all attributes.The root cause of the soft molded tip disengagement could not be determined and therefore, no corrective actions were taken.Complaints relating to the soft molded tip disengagement will continue to be monitored and trended.

• Brand Name: QCOMP YANK SUCT HNDLE 40
• 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: 20107196
• Report Number: 0001419181-2024-00008
• Device Sequence Number: 8475165
• Product Code: JOL
• UDI-Device Identifier: 50618029841358
• UDI-Public: 50618029841358
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6429
• Device Catalogue Number: 6429
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown