MAUDE Adverse Event Report: WESTMED LLC ADULT NASAL CANNULA, SOFT TIP, 7' TUBING W/THREADED NUT

Model Number	0567
Medical Device Problem Codes	Failure to Disconnect (2541); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Connections sometimes not secure enough.
Additional Manufacturer Narrative
All information reasonably known as of 24 july 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21c.F.R.803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.
Additional Manufacturer Narrative
All information reasonably known as of 24 july 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint 09981.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an airlife product is defective or caused serious injury.The complaint reported that "connections are sometimes not secure enough." an investigation was conducted based on the information provided.According to the complaint report, no patient was affected.Since no photos, videos, or samples were provided, we were unable to evaluate and determine an issue with the device.As a result, the complaint could not be confirmed, and no root cause was determined.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the first (1) complaint reported for part number 0567 for "connection/disconnection(s).There was one complaint reported for part number 0567 during the same timeframe for non-functional component(s).We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
Connections sometimes not secure enough.

• Brand Name: ADULT NASAL CANNULA, SOFT TIP, 7' TUBING W/THREADED NUT
• Common Device Name: ADULT NASAL CANNULA, SOFT TIP, 7' TUBING W/THREADED NUT
• 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: 19821721
• Report Number: 2028807-2024-00017
• Device Sequence Number: 8612723
• Product Code: CAT
• UDI-Device Identifier: 00709078002977
• UDI-Public: (01)00709078002977(10)478054
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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: 0567
• Device Catalogue Number: N/A
• Device Lot Number: 478054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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