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

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2020

Event Type  Injury  

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 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.

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
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9802133
• MDR Text Key: 188824290
• Report Number: 8030673-2020-00077
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 10190752116603
• UDI-Public: (01)10190752116603(10)0004100451
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR