MAUDE Adverse Event Report: SAGE PRODUCTS LLC TOC SOS W/PROX-MM-6PK 50; SUCTION SWAB

Model Number	6550
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The partial device and photographs were returned for evaluation.The manufacturer received a detached green foam head, however the remainder of the swab straw and suction port were not returned for investigation.Evaluation of the photograph and returned device revealed the green foam head appeared to have undergone damage.The partial green foam head had one corner missing which would indicate the green foam head underwent a tearing or ripping to separate.A portion of the suction oral swab straw can be seen inside of the disengaged green foam head.This would indicate the green foam did not disengage due to an inadequate amount of adhesive, but instead the straw had to have been exposed to a stress that caused the swab straw to crack.This damage is consistent with stress seen from biting the suction oral swab.Production history records for the reported lot number were reviewed and all in-process quality checks indicated passing results.Per packaging instructions, it states, "use a bite block when performing oral care on patients with altered levels of consciousness, or those who cannot comprehend commands." the root cause of the reported foam head disengagement is most likely user error due to the patient biting down on the swab foam head and not following directions to use a bite block.
Event or Problem Description
Report received of foam disengagement due to user error.On (b)(6) 2018, oral care was performed on a male sedated and ventilated patient.The reporter stated during oral care the patient involuntarily bit down on the suction oral swab stick and the green foam disengaged from the stick.The reporter stated the foam was successfully removed from the patient's oral cavity and no injury occurred to the patient or nurse.The reporter stated the incident occurred during initial use of the product and a bite block was not used.Although requested, no additional information provided.

• Brand Name: TOC SOS W/PROX-MM-6PK 50
• Common Device Name: SUCTION SWAB
• Manufacturer (Section D): SAGE PRODUCTS LLC; 3909 three oaks road; cary IL 60013
• MDR Report Key: 7571737
• Report Number: 0001419181-2018-00021
• Device Sequence Number: 1979825
• Product Code: JOL
• UDI-Device Identifier: 50618029800652
• UDI-Public: 50618029800652
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: 01/21/2020
• Device Model Number: 6550
• Device Catalogue Number: 6550
• Device Lot Number: 64814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1