MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; E/T TUBE CUFFED 3.0MM 12FR

Model Number	1-7333-30
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Respiratory Insufficiency (4462)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reportable as reported to fda, and the patient needed racemic epi treatment for stridor.
Event or Problem Description
Clinician felt a "popping" as the cuff was being removed. the patient needed racemic epi for stridor later in the day.
Event or Problem Description
Clinician felt a "popping" as the cuff was being removed. the patient needed racemic epi for stridor later in the day.
Additional Manufacturer Narrative
Reportable as reported to fda, and the patient needed racemic epi treatment for stridor.Complaint not confirmed as no photo or returned material was provided.Sent complaint information to the supplier.Reviewed complaint history for the 24 months preceding the complaint reporting date.There was one complaint for the part in that timeframe, there is no trending issue.Root cause of noise is likely due to one of the following: the cuff was at least partially inflated, or the cuff snagged on something such as scar tissue or a tumor in the airway.Pulled most similar available device part number 1-7333-25 to perform visual inspection.No non-conformances were found.Sent resolution to the customer.

• Brand Name: SUNMED LLC
• Common Device Name: E/T TUBE CUFFED 3.0MM 12FR
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 16773055
• Report Number: 1314417-2023-00008
• Device Sequence Number: 11548291
• Product Code: BTR
• UDI-Device Identifier: 10889483040508
• UDI-Public: 10889483040508
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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: Health Professional
• Device Model Number: 1-7333-30
• Device Catalogue Number: 1-7333-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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