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

Model Number	6512
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the affected product, nor photographs or lot information provided to aid in the investigation.Therefore, neither a visual/functional inspection nor a product history review could be performed.A labeling review was performed.However, there was no reported information to determine if the instructions for use were followed.Quality checks are performed every two (2) hours on the suction swabs to ensure they are being manufactured to specifications.The product will be rejected if it does not pass the in-process quality check.Therefore, the root cause of the reported complaint could not be determined.Complaints related to the suction swabs breaking will continue to be monitored and trended.
Event or Problem Description
Report received of suction swab breaking apart.No other details were provided.No lot information or photos were provided.No information regarding the location or availability of the device for return was provided.Although additional information was requested, no additional information was received.
Additional Manufacturer Narrative
Additional information received.Reporter stated the foam on an unknown number of suction swabs partially tore after initial use.No disengagements occurred.This event is not reportable.
Event or Problem Description
Additional information received.Reporter stated the foam on an unknown number of suction swabs partially tore after initial use.No disengagements occurred.This event is not reportable.

• Brand Name: TOC SOS W/PROX 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: 20926480
• Report Number: 0001419181-2024-00016
• Device Sequence Number: 5055902
• Product Code: JOL
• UDI-Device Identifier: 00618029800633
• UDI-Public: (01)00618029800633
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: Other
• Device Model Number: 6512
• Device Catalogue Number: 6512
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/10/2025
• 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
• Patient Sex: Unknown