MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC SOS W/CORINZ 100; SUCTION SWAB

Catalog Number	6145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.The lot information was not provided.Therefore, a product history review could not be performed.Every swab undergoes a pull test to ensure the swab is securely attached, if the swab fails this test, it will be rejected.The root cause of the foam disengagement could not be determined and therefore, no corrective actions were taken.Complaints relating to swab disengagements will continue to be monitored and trended.
Event or Problem Description
Report received of a swab disengagement.Reporter stated foam on the suction swab disengaged in one piece into the patient¿s mouth.The patient was a 30-year-old male and was orally intubated.It is unknown when exactly the swab became disengaged in the patient¿s mouth.The disengaged swab was discovered when the patient expectorated it.The patient experienced copious secretions for 3-4 days before expectorating the swab.The secretions dissipated after the swab was expectorated.This led the reporter to conclude that the swab contributed to the patient¿s copious secretions, and therefore delayed his extubation.However, the circumstances at the time of the swab disengagement are not known, as the event was not reported by staff at the time of the occurrence.Per the reporter, after the patient expectorated the swab head, the secretions dissipated, the patient was successfully extubated and transferred from the icu to a step-down unit.The lot number for the device was not available.The device has been discarded and photos are not available.

• Brand Name: TOC SOS W/CORINZ 100
• Common Device Name: SUCTION 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: maeve linder ; 3909 three oaks road; cary, IL 60013 ; 8154554700
• MDR Report Key: 20510302
• Report Number: 0001419181-2024-00010
• Device Sequence Number: 15586494
• Product Code: JOL
• UDI-Device Identifier: 50618029821510
• UDI-Public: 50618029821510
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 10/22/2024

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: Other
• Device Catalogue Number: 6145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR
• Patient Sex: Male