MAUDE Adverse Event Report: SECURISYN MEDICAL SUNMED LLC; SOLIDAIRITY FLEX ORAL ENDOTRACHEAL TUBE STABILIZER

Model Number	4.1500.2DS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Choking (2464)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The s-flex breaking could cause the small piece to become a choking hazard.
Event or Problem Description
S-flex had broken where the tower meets the lateral slide.
Additional Manufacturer Narrative
The s-flex breaking could cause the small piece to become a choking hazard.Summary: investigation into reported complaints (b)(4) indicate a lack of system requirements during design and product launch.Revision of the design input/output files are being conducted for airlife product acquisition.Ra: no associated risk management files for solidairity product owned by airlife at time of clinical trials.
Event or Problem Description
S-flex had broken where the tower meets the lateral slide.

• Brand Name: SUNMED LLC
• Common Device Name: SOLIDAIRITY FLEX ORAL ENDOTRACHEAL TUBE STABILIZER
• Manufacturer (Section D): SECURISYN MEDICAL; 9609 s. university blvd; littleton CO 80163
• Manufacturer (Section G): SECURISYN MEDICAL, LLC; 9609 s. university blvd; littleton CO 80163
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 17083133
• Report Number: 1314417-2023-00013
• Device Sequence Number: 6260370
• Product Code: CBH
• UDI-Device Identifier: 00860009077928
• UDI-Public: 00860009077928
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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 Model Number: 4.1500.2DS
• Device Catalogue Number: 4.1500.2DS
• Device Lot Number: SY230206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown