MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ADULT AIRWAY TRAY

Catalog Number	ACC010469A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024 "patient needed to be intubated, respiratory therapist obtained sealed airway box from rapid response team cart and respiratory therapist noted that airway box was missing both 7.5 and 8.0 endotracheal tubes from box".Per the facility the patient was not injured and did not require medical intervention.The sample is not available 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
According to the facility on (b)(6) 2024 "patient needed to be intubated, respiratory therapist obtained sealed airway box from rapid response team cart and respiratory therapist noted that airway box was missing both 7.5 and 8.0 endotracheal tubes from box".

• Common Device Name: ADULT AIRWAY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20773599
• Report Number: 1423395-2024-00503
• Device Sequence Number: 15457222
• Product Code: CAI
• UDI-Device Identifier: 40195327356935
• UDI-Public: 40195327356935
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 11/25/2024

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
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: ACC010469A
• Device Lot Number: 24EDA505
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 11/25/2024
• 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
• Patient Sex: Unknown