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

Catalog Number	6513
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter discarded the involved device but did provide a photograph and lot information for review.Production history records for the reported lot were reviewed.All in process quality checks indicated passing results.A labeling review of the finished good was performed.The instructions for use state, use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use.If not, remove any particles from oral cavity.The review of the label is adequate for the intended use of the device and did not contribute to the reported failure.Without the returned product or further information, a definitive root cause could not be determined.
Event or Problem Description
Report received of a swab disengagement while using sage toothette oral care suction swab device.Reporter stated on (b)(6) 2021 a nurse was performing oral care on an intubated and sedated patient when the plastic straw of the suction swab broke into two pieces.The nurse was able to remove the swab head with attached piece of plastic from the patients mouth without incident.Although, the reporter stated the patient did not bite down on the straw of the suction swab; a bite block was not in use during oral care.Lot information and a photograph were provided.Though requested, no additional information was available.

• Brand Name: TOC SOS W/PROX-MM 100
• Common Device Name: SUCTION ORAL SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 11440028
• Report Number: 0001419181-2021-00004
• Device Sequence Number: 14472158
• Product Code: JOL
• UDI-Device Identifier: 50618029800645
• UDI-Public: 50618029800645
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

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: 09/20/2022
• Device Catalogue Number: 6513
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58