MAUDE Adverse Event Report: WESTMED LLC WESTMED LLC; ADULT CANNULA SOFT TIPPED W/7' GREEN TUBING

Model Number 0556

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The leaks or loose pipes at the y connector would interrupt the patient therapy, and the patient could become hypoxia.

Event Description

Cannulas are leaking. .

Event Description

Cannulas are leaking. .

Manufacturer Narrative

The leaks or loose pipes at the y connector would interrupt the patient therapy, and the patient could become hypoxia no images or returned inventory provided, complaint is unconfirmed.The issue is stated as the cannula is leaking.There was nothing in inventory to review as well as nothing out of the ordinary for the dhr's.In the last 24 months, there have been 2 related complaints.Root cause cannot be determined at this time.However, likely root cause is little or no bonding agent applied to bonding location during assembly.Risk assessment: for patient risk, rma-20017f, step r87 issue is stated as "low oxygen delivery", potential hazard being "loss/delay in oxygen therapy leading to hypoxia", causation "cannula tubing deteriorates resulting in leaks prior to first use", s=8, o=1, rpn=8 (less than 25, therefore risk is acceptable).For regulatory risk the lack of directly related complaints indicates a low-risk.

• Brand Name: WESTMED LLC
• Type of Device: ADULT CANNULA SOFT TIPPED W/7' GREEN TUBING
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18196862
• MDR Text Key: 328959851
• Report Number: 2028807-2023-00032
• Device Sequence Number: 1
• Product Code: CAT
• UDI-Device Identifier: 00709078002960
• UDI-Public: 00709078002960
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0556
• Device Catalogue Number: 0556
• Device Lot Number: 032622J03, 032022J03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other