MAUDE Adverse Event Report: WESTMED LLC ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING

Model Number	0556
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The leaks or loose pipes at the y connector would interrupt the patient therapy, and the patient could become hypoxia.
Event or Problem Description
Cannulas are leaking. .
Event or Problem Description
Cannulas are leaking. .
Additional 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.
Additional 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 (b)(4) 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.Udi related data quality updates only.
Event or Problem Description
Cannulas are leaking. .

• Brand Name: ADULT SOFT TIP CANNULA WITH 7' 85 SHORE GREEN TUBING
• Common Device Name: ADULT SOFT TIP CANNULA WITH 7' 85 SHORE 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
• Report Number: 2028807-2023-00032
• Device Sequence Number: 6554120
• Product Code: CAT
• UDI-Device Identifier: 00709078002960
• UDI-Public: (01)00709078002960(10)032622J03,(01)00709078002960(10)032022J03
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0556
• Device Catalogue Number: 0556
• Device Lot Number: 032622J03, 032022J03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 10/25/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 01/30/2024; 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown