MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TUBE, ENDOTRACHEAL,CUFF, STYLET, 7.0MM

Catalog Number	DYNJAETC70S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that, "the item was found to be faulty during use on a patient.The item fell apart while being inserted into the patient".
Additional Manufacturer Narrative
The customer reported that, "the item was found to be faulty during use on a patient.The item fell apart while being inserted into the patient".There was no further information.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.
Additional Manufacturer Narrative
Updated: d9- device returned to manufacturer/ date returned to manufacturer h3-device evaluated by manufacturer h6-type of investigation (b) and investigation conclusions (d).

• Common Device Name: TUBE, ENDOTRACHEAL,CUFF, STYLET, 7.0MM
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19537671
• Report Number: 1417592-2024-00651
• Device Sequence Number: 6424986
• Product Code: BTR
• UDI-Device Identifier: 20888277724799
• UDI-Public: 20888277724799
• 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,Followup
• Report Date (Section B): 06/21/2024

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: DYNJAETC70S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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