MAUDE Adverse Event Report: VYAIRE MEDICAL. AIRLIFE OXYGEN TUBING 7' (2.1M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED; CANNULA, NASAL, OXYGEN

Model Number	AIRLIFE¿ OXYGEN TUBING 7' (2.1M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported that the sample device is not available for analysis.But the lot number is provided therefore device history review can be obtain.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the airlife oxygen tubing is leaking at the same connection site as the green cuff, where the tubing initially meets the cuff site oxygen was leaking profusely.This issue occurred while connected to a patient and the tube was replaced with a new set.
Additional Manufacturer Narrative
Updated: d4, g4, g7, h2, h4 and h10.Result of investigation: the device history record (dhr) review did not show any deviations to manufacturer specification.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.

• Brand Name: AIRLIFE OXYGEN TUBING 7' (2.1M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9802133
• Report Number: 8030673-2020-00077
• Device Sequence Number: 643402
• Product Code: CAT
• UDI-Device Identifier: 10190752116603
• UDI-Public: (01)10190752116603(10)0004100451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: AIRLIFE¿ OXYGEN TUBING 7' (2.1M) CRUSH RESISTANT OXYGEN TUBING, VINYL TIPPED
• Device Catalogue Number: 001302
• Device Lot Number: 0004100451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR