MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP 7.5MM, HVLP,CUFFED,ET TUBE

Model Number	DYND43075
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the end of the procedure, when the patient was already intubated, the facility noticed a low return volume and an audible cuff leak requiring re-intubation.
Additional Manufacturer Narrative
This medwatch was received in a paper format via mail from the fda and delivered to an unattended mailbox due to covid-19 workplace policy restrictions.Upon discovery the report was investigated per procedure and the mail receiving process has been modified.User facility medwatch number: mw5107479.It was reported that at the end of the procedure, when the patient was already intubated, the facility noticed a low return volume and an audible cuff leak.The staff attempted to troubleshoot by passing the suction catheter and re-inflating the cuff however after 30 seconds the audible leak and low return volumes were again noted.The patient was re-intubated by the doctor.There was no impact to the patient's stability related to the event.The patient was monitored and remained in stable condition.The sample was not returned for evaluation.A definitive root cause was not able to be determined.No additional information is available.Due to the reported incident and 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.

• Brand Name: 7.5MM, HVLP,CUFFED,ET TUBE
• Common Device Name: 7.5MM, HVLP,CUFFED,ET TUBE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 14696550
• Report Number: 1417592-2022-00079
• Device Sequence Number: 4677601
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND43075
• Device Catalogue Number: DYND43075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 06/15/2022
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Unknown
• Patient Weight: 102 KG