MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; 7.5MM, HVLP,CUFFED,ET TUBE

Model Number	DYND43075
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Pilot balloon not maintaining pressure.
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2023 a patient required a "difficult" emergency intubation.After intubation, it was reported that the pilot balloon was not maintaining pressure.Customer reports this could have been torn due to the multiple attempts during intubation of patient.It was reported the cuff was checked prior to intubation.According to the customer, due this the patient required reintubation.After the reintubation the patient was reported to be in stable condition.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.

• Brand Name: Medline Industries, Inc.
• Common Device Name: 7.5MM, HVLP,CUFFED,ET TUBE
• 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: 16808134
• Report Number: 1417592-2023-00185
• Device Sequence Number: 16893295
• Product Code: BTR
• UDI-Device Identifier: 10080196726325
• UDI-Public: 10080196726325
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/25/2023

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: DYND43075
• Device Catalogue Number: DYND43075
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/25/2023
• 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