MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 7.5MM, HVLP,CUFFED,ET TUBE

Catalog Number	DYND43075
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a particulate originating from the packaging went inside the endotracheal tube.Reportedly, this particulate was noticed when the endotracheal tube was already placed in the patient's airway and before the first breath is to be given through the resuscitation bag.It was reported that the endotracheal tube was removed and replaced with another.Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details.There was no serious injury reported related to the event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause could not be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a particulate originating from the packaging got inside the endotracheal tube.

• Common Device Name: 7.5MM, HVLP,CUFFED,ET TUBE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8023569
• Report Number: 1417592-2018-00119
• Device Sequence Number: 1436123
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2018

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: DYND43075
• Device Lot Number: 59218050746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/31/2018
• 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