MAUDE Adverse Event Report: SALTER LABS 25 FOOT GREEN OXYGEN TUBING; TUBING, PRESSURE AND ACCESSORIES

Model Number 2025G-25

Device Problems Disconnection (1171); Gas/Air Leak (2946)

Patient Problem Numbness (2415)

Event Date 04/03/2023

Event Type  Injury  

Event Description

On two separate occasions, 25 foot oxygen tubing that should be one solid unit of tubing became separated at the juncture where the tubing meets the connector end of the tubing.It appears that the two parts were never fused together as tubing usually is.I was wearing the tubing connected to my oxygen canula on both occasions and tubing came apart during normal household activities.The first occasion resulted in numbness in my extremities before i noticed the disconnection and could have been deadly had i gone to sleep without discovering the problem.Initially i assumed that i received a rare, faulty hose the first time this happened, but after the second hose failed, realized this is a larger problem and that other oxygen users should be made aware.Reference report: mw5116420.

• Brand Name: 25 FOOT GREEN OXYGEN TUBING
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): SALTER LABS
• MDR Report Key: 16700555
• MDR Text Key: 313006100
• Report Number: MW5116419
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2025G-25
• Device Catalogue Number: 2025G-25
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening