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	Foreign Body In Patient (2687)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter returned three (3) same lot samples and provided photographs of the involved device for evaluation.The three same lot sample yankauer¿s returned by the reporter revealed no physical abnormalities.Visual examination of the three (3) same lot samples revealed the expected circular melted pattern which is evidence that the soft tip over-molds were properly molded and melted onto the hard straw.Manual separation of the same lot sample soft tip over-molds was attempted.None of the three (3) soft tips over-molds could be removed.This indicates all three (3) same lot samples were manufactured per specifications.Review of the provided photograph of the involved device revealed one (1) yankauer with the soft tip over-mold disengaged from the hard straw of the device.The hard straw showed evidence of the expected circular melted pattern where the soft tip over-mold was molded and melted onto the hard straw.This would indicate that the material was manufactured correctly.Some signs of use on the hard straw were visualized in the photograph.The disengaged tip showed both discoloration and signs of damage.It is impossible to determine from the photograph if the damage to the soft tip over-mold occurred during use or during the medical intervention required to remove the device from the patient¿s tracheal stoma.Production history records for the reported lot were reviewed.During manufacturing, a pull test is performed.The soft tip over-mold and suction port are grabbed and pulled by the equipment to test correct adherence to the hard straw.This test is performed on 100% of the product.All in-process quality checks indicated passing results.A labeling review of the finished good was performed.The instructions for use state, ¿single patient oral use.¿ the reporter stated the product was never used in the oral cavity and used to remove secretions from the tracheal stoma.The instructions were not followed correctly by the reporter.The review of the label is adequate for the intended use of the device and did not contribute to the reported failure.A root cause for the disengagement could not be established.The reporter used the device outside of the device¿s intended purpose which contributed to the adverse event experienced by the reporter.Due to the review of the photograph, examination of the returned same lot samples, review of labeling, and review of the product history and manufacturing records, there is insufficient evidence to conclude the reported issue was attributable to a quality defect or manufacturing operations.Reporter refused to release product.
Event or Problem Description
Report received of a yankauer suction tip disengagement.Reporter is a lay person.Reporter stated on (b)(6) 2019, he executed self-suctioning of his tracheal stoma while at home.Reporter stated on initial use of device, he used the yankauer, ¿to clean my stoma.¿ reporter stated the soft tip over-mold of the yankauer disengaged inside his tracheal stoma and he was unable to remove the disengaged tip.Reporter stated he was not in respiratory distress and went to the emergency department at 0930 hours.Reporter stated that at 1500 hours the disengaged tip was successfully removed by the emergency room physician using, ¿an oscilloscope with clip attachment.¿ reporter stated he experienced soreness and coughing following the intervention.Reporter advised he has never used the product in his oral cavity.Reporter was advised the product, as specified on the labeling, is nonsterile and the intended use is for oral cavity suctioning.Reporter provided a picture of the involved device, however, refused to return the involved device for evaluation.Reporter returned three same lot sample devices for evaluation.Although requested, no additional information was available.

• 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
• MDR Report Key: 8440304
• Report Number: 0001419181-2019-00003
• Device Sequence Number: 16398700
• Product Code: JOL
• UDI-Device Identifier: 50618029841358
• UDI-Public: 50618029841358
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 03/21/2019

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: Lay User/Patient
• Device Model Number: 6429
• Device Catalogue Number: 6429
• Device Lot Number: 63648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR