MAUDE Adverse Event Report: SALTER LABS N/A; NASAL CANNULA (ADULT) WITH 7' (2.1 M) SUPPLY TUBE

Model Number	1053-7
Medical Device Problem Codes	Blocked Connection (2888); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during patient use, the nasal cannula was obstructed at the connection between the tubing and nasal prongs.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2025 has been included in the 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 is identified as complaint (b)(4).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 a airlife product is defective or causes serious injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 14 march 2025 has been included in the 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 is identified as complaint (b)(4).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 a airlife product is defective or causes serious injury.The complaint stated, "patient reports that the glasses are blocked, and oxygen flow does not pass through the cannula." no patient injuries or adverse effects were reported.Based on the photos provided, the complaint was confirmed.A possible root cause, as observed in the two images submitted, appears to be a lack of bonding to secure the tubing in the correct position.This may have allowed the tube to shift across the nasal glasses causing lack of oxygen flow.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 sixth complaint reported for part number 1053-7-50 for "customer misuse." there were four other complaints reported for part number 1053-7-50 during the same timeframe.A resolution letter was sent to the customer.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
It was reported that during patient use, the nasal cannula was obstructed at the connection between the tubing and nasal prongs.

• Brand Name: N/A
• Common Device Name: NASAL CANNULA (ADULT) WITH 7' (2.1 M) SUPPLY TUBE
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21612810
• Report Number: 3000219639-2025-00022
• Device Sequence Number: 18058069
• Product Code: CAT
• UDI-Device Identifier: 00607411101113
• UDI-Public: (01)00607411101113
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 1053-7
• Device Catalogue Number: 1053-7
• Device Lot Number: UNKNOWN
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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