MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TUBE, ENDOTRACHEAL,CUFF, STYLET, 6.5MM

Catalog Number	DYNJAETC65S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the facility the patient was intubated and ventilated and "the item spontaneously fell apart which was identified after rrt troubleshooting why the patient was not getting tidal volumes on the ventilator".Per the facility the "piece was taken off and replaced".The sample was requested for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Per the facility the patient was intubated and ventilated and "the item spontaneously fell apart which was identified after rrt troubleshooting why the patient was not getting tidal volumes on the ventilator".

• Common Device Name: TUBE, ENDOTRACHEAL,CUFF, STYLET, 6.5MM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19745836
• Report Number: 1417592-2024-00747
• Device Sequence Number: 6532253
• Product Code: BTR
• UDI-Device Identifier: 20888277724782
• UDI-Public: 20888277724782
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2024

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?: No
• Device Catalogue Number: DYNJAETC65S
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown