MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TUBE,ENDOTRACH,HVLP CUFF,MURPHY,7.5MM

Catalog Number	DYNJAETC75
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that when the endotracheal tube was connected to the anesthesia machine, the air inside the endotracheal tube's balloon was lost.During insertion, it is unknown how much air was used to inflate the balloon of the endotracheal tube.Per report, no lubricant was used during insertion of the endotracheal tube and the tube was secured to the patient using tape.After it was noted that the endotracheal tube's balloon lost air, the patient was extubated and a new endotracheal tube was inserted.There was no serious injury reported related to this event.Due to the reported incident of the endotracheal tube's balloon losing air and the required re-intubation, this medwatch is being filed.The sample is available and had been returned for evaluation.The endotracheal tube was noted with a torn balloon.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that when the endotracheal tube was connected to the anesthesia machine, air inside the endotracheal tube's balloon was lost.The patient was extubated and a new endotracheal tube was inserted.

• Common Device Name: TUBE,ENDOTRACH,HVLP CUFF,MURPHY,7.5MM
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8839219
• Report Number: 1417592-2019-00127
• Device Sequence Number: 19208590
• Product Code: BTR
• UDI-Device Identifier: 10888277689572
• UDI-Public: 10888277689572
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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 Catalogue Number: DYNJAETC75
• Device Lot Number: 59218112629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention