MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TUBE,ENDOTRACH,HVLP,CUFF,MURPHY,3.0MM

Model Number	DYNJAETC30
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the cuff is "too large and rigid for safe use in infants".It was reported that the "cuff is too large and positioning the entire cuff below the cords risks unintended endobronchial intubation".The customer reported they were unable to remove ett which caused the patient to be admitted to the icu.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Unable to remove tube, leading to icu admission.

• Brand Name: Medline
• Common Device Name: TUBE,ENDOTRACH,HVLP,CUFF,MURPHY,3.0MM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17050321
• Report Number: 1417592-2023-00240
• Device Sequence Number: 7040044
• Product Code: BTR
• UDI-Device Identifier: 10888277689480
• UDI-Public: 10888277689480
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 06/02/2023

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?: No
• Device Model Number: DYNJAETC30
• Device Catalogue Number: DYNJAETC30
• Device Lot Number: 59222112653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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